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Found 8 results
510(k) Data Aggregation
K Number
K971088Device Name
OPPORTUNITY INCISION AND DRAINAGE TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
EFQ, K97
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Incision and Drainage Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing incision and drainage procedures.
Device Description
Not Found
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K Number
K971089Device Name
OPPORTUNITY, INC. LACERATION TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
KKX, K97
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Laceration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing laceration procedures.
Device Description
Not Found
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K Number
K971090Device Name
OPPORTUNITY DRESSING CHANGE TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
KMF, K97
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Dressing Change Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing in the change of dressings.
Device Description
Not Found
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K Number
K971091Device Name
OPPURTUNITY TRACHEOSTOMY CARE KIT
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
KMF, K97
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Tracheostomy Care Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing tracheostomy procedures.
Device Description
Not Found
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K Number
K971093Device Name
OPPORTUNITY I.V. START KIT
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
MGP, K97
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s I.V. Start Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing I.V. start procedures.
Device Description
Not Found
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K Number
K971095Device Name
OPPORTUNITY SUTURE REMOVAL KIT
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16
(176 days)
Product Code
EFQ, K97
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Suture Removal Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing suture removal.
Device Description
Not Found
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K Number
K971061Device Name
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-06-11
(79 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.
Device Description
Bone Marrow Biopsy and Aspiration Tray
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K Number
K971062Device Name
OPPORTUNITY INC. GENERAL PURPOSE TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-06-09
(77 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
OPPORTUNITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.
Device Description
Not Found
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