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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 And Burn, Occlusive
510(k) Number K992005
Device Name GILTECH PLUS TRANSPARENT 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
Classification Product Code
MGP  
Date Received06/15/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
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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