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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 K952702
Device Name DERMA SEAL
Applicant
TTL MEDICAL
10537 LEXINGTON DR.
KNOXVILLE,  TN  37932
Applicant Contact H. CLAY WILSON
Correspondent
TTL MEDICAL
10537 LEXINGTON DR.
KNOXVILLE,  TN  37932
Correspondent Contact H. CLAY WILSON
Regulation Number880.5240
Classification Product Code
FPX  
Date Received06/13/1995
Decision Date 06/28/1995
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
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