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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K935843
Device Name BE-SAFE
Applicant
Mathis-Koolpe, Inc.
161 Serrill Rd.
Elkins Park,  PA  19027
Applicant Contact ROBERT P MATHIS, M.D.
Correspondent
Mathis-Koolpe, Inc.
161 Serrill Rd.
Elkins Park,  PA  19027
Correspondent Contact ROBERT P MATHIS, M.D.
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/08/1993
Decision Date 06/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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