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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, Occlusive
510(k) Number K891459
Device Name STERILE BURNNET PRE-CUT (VARIOUS SIZES)
Applicant
Western Medical, Ltd.
1390 Flynn Rd., Unit F
Camarillo,  CA  93012
Applicant Contact GLORIA MARGO
Correspondent
Western Medical, Ltd.
1390 Flynn Rd., Unit F
Camarillo,  CA  93012
Correspondent Contact GLORIA MARGO
Regulation Number878.4020
Classification Product Code
NAD  
Date Received03/15/1989
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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