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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Hydrogel Without Drug And/Or Biologic
510(k) Number K992094
Device Name GILTECH PLUS HYDROGEL SKIN DRESSING
Applicant
Giltech Plus, Inc.
P.O. Box 728
Milford,  PA  18337
Applicant Contact WILLIAM J GILIAM
Correspondent
Giltech Plus, Inc.
P.O. Box 728
Milford,  PA  18337
Correspondent Contact WILLIAM J GILIAM
Regulation Number878.4022
Classification Product Code
NAE  
Date Received06/21/1999
Decision Date 09/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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