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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K953102
Device Name BLOODBORNE PATHOGEN KIT
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
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/03/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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