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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 K943141
Device Name B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS
Applicant
MED-SAFE SYSTEMS, INC.
4665 NORTH AVE.
OCEANSIDE,  CA  92056 -3590
Applicant Contact VIRGINIA M SHILLINGTON
Correspondent
MED-SAFE SYSTEMS, INC.
4665 NORTH AVE.
OCEANSIDE,  CA  92056 -3590
Correspondent Contact VIRGINIA M SHILLINGTON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/29/1994
Decision Date 11/07/1994
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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