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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 K950554
Device Name NORTH BLOODBORNE PATHOGEN RESPONSE KIT
Applicant
North Safety Products
1515 Elmwood Rd.
Rockford,  IL  61103
Applicant Contact JAMES WRIGHT
Correspondent
North Safety Products
1515 Elmwood Rd.
Rockford,  IL  61103
Correspondent Contact JAMES WRIGHT
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/03/1995
Decision Date 06/28/1995
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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