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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K923400
Device Name DERMCO A-I
Applicant
DERMACO, INC.
1440 GROVE ST.
DENVER,  CO  80204
Applicant Contact JOHN MILES
Correspondent
DERMACO, INC.
1440 GROVE ST.
DENVER,  CO  80204
Correspondent Contact JOHN MILES
Regulation Number880.5240
Classification Product Code
KGX  
Date Received07/10/1992
Decision Date 10/06/1992
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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