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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 K946338
Device Name CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
Applicant
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Applicant Contact HOWARD GERSON
Correspondent
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Correspondent Contact HOWARD GERSON
Classification Product Code
MGP  
Date Received12/29/1994
Decision Date 03/29/1995
Decision Substantially Equivalent (SESE)
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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