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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K842621
Device Name SUTURE STRIP
Applicant
Genetic Laboratories, Inc.
1385 Dentennial Dr.
St. Paul,  MN  55113
Applicant Contact DANIEL G HOLMAN
Correspondent
Genetic Laboratories, Inc.
1385 Dentennial Dr.
St. Paul,  MN  55113
Correspondent Contact DANIEL G HOLMAN
Regulation Number880.5240
Classification Product Code
FPX  
Date Received07/05/1984
Decision Date 10/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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