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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name First Aid Kit With Drug
510(k) Number K940249
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
LRR  
Date Received01/19/1994
Decision Date 10/03/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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