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Found 3 results
510(k) Data Aggregation
K Number
K991437Device Name
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
Manufacturer
WELLS JOHNSON CO.
Date Cleared
1999-08-30
(126 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
WELLS JOHNSON CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
General surgical fluid irrigation and infiltration.
Device Description
Not Found
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K Number
K984448Device Name
BIRCOLL BALLOON DISSECTOR
Manufacturer
WELLS JOHNSON CO.
Date Cleared
1999-01-28
(45 days)
Product Code
FZW, LCJ
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
WELLS JOHNSON CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION
Device Description
Not Found
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K Number
K971580Device Name
UAS ULTRASONIC ASPIRATOR SYSTEM
Manufacturer
WELLS JOHNSON CO.
Date Cleared
1997-12-09
(223 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WELLS JOHNSON CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.
Device Description
Not Found
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