FDA 510K (K832448) TRIFLEX SURGEON'S GLOVES
FDA 510K (K832448) TRIFLEX SURGEON'S GLOVES
Device Classification Name Surgeon'S Gloves
510(k) Number K832448
Device Name TRIFLEX SURGEON'S GLOVES
Applicant TRAVENOL LABORATORIES, S.A.
Regulation Number 878.4460
Classification Product Code KGO
Date Received 07/25/1983
Decision Date 01/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Total pages: 57
Fully redacted pages: 45
Content pages: 12
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