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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 K840609
Device Name SKIN TECH. ISOTEX 86L
Applicant
LECTEC CORP.
10205 CROSSTOWN CIRCLE
EDEN PRAIRIE,  MN  55344 -
Applicant Contact PETER JACHIMOWIC
Correspondent
LECTEC CORP.
10205 CROSSTOWN CIRCLE
EDEN PRAIRIE,  MN  55344 -
Correspondent Contact PETER JACHIMOWIC
Regulation Number880.5240
Classification Product Code
KGX  
Date Received02/13/1984
Decision Date 10/31/1984
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
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