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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K940635
Device Name SAFE-1(TM) SYRINGE
Applicant
Safety 1st Medical, Inc.
30100 Town Center Dr.
Suite O-290
Laguna Niguel,  CA  92677
Applicant Contact CHERYL A WEATHERFORD
Correspondent
Safety 1st Medical, Inc.
30100 Town Center Dr.
Suite O-290
Laguna Niguel,  CA  92677
Correspondent Contact CHERYL A WEATHERFORD
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received02/14/1994
Decision Date 01/31/1995
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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