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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K023266
Device Name PRIMAGARD SURGICAL GOWNS
Applicant
Primeline Medical Products, Inc.
1591 Four Rod Rd.
Alden,  NY  14004
Applicant Contact DAVID POWER
Correspondent
Primeline Medical Products, Inc.
1591 Four Rod Rd.
Alden,  NY  14004
Correspondent Contact DAVID POWER
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/30/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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