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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guard, Skin Graft
510(k) Number K943871
Device Name AQUAPLAST TIE DOWN DRESSING
Applicant
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481 -0635
Applicant Contact JOHN R KIRK
Correspondent
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481 -0635
Correspondent Contact JOHN R KIRK
Regulation Number878.4014
Classification Product Code
LZM  
Date Received08/08/1994
Decision Date 09/30/1994
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
Predetermined Change
Control Plan Authorized		 No
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