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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, silk
510(k) Number K942234
Device Name VISITEC PRECISE-POINT
Applicant
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Applicant Contact DAVID A CLAPP
Correspondent
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Correspondent Contact DAVID A CLAPP
Regulation Number878.5030
Classification Product Code
GAP  
Subsequent Product Codes
GAT   GAW  
Date Received05/09/1994
Decision Date 07/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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