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Found 3 results
510(k) Data Aggregation
K Number
K972634Device Name
ULTRACELL SUCTION SPONGE
Manufacturer
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-12-17
(156 days)
Product Code
GDY, HBA, HOZ
Regulation Number
878.4450Why did this record match?
Product Code :
GDY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.
Device Description
Not Found
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K Number
K960236Device Name
CPR LAP SPONGES
Manufacturer
CUSTOM PACK RELIABILITY
Date Cleared
1996-03-28
(72 days)
Product Code
GDY, FRG, GER
Regulation Number
878.4450Why did this record match?
Product Code :
GDY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Removal of suture from the epidermis.
Device Description
Not Found
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K Number
K955599Device Name
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
Manufacturer
STRYKER CORP.
Date Cleared
1996-02-22
(76 days)
Product Code
GDY
Regulation Number
878.4450Why did this record match?
Product Code :
GDY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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