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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 K991039
Device Name EASYSAFE RETRACTING NEEDLE SYRINGE
Applicant
Saf-T-Med, Inc.
1250 S. Grove, Suite 200
Barrington,  IL  60010
Applicant Contact JAMES ERBS
Correspondent
Saf-T-Med, Inc.
1250 S. Grove, Suite 200
Barrington,  IL  60010
Correspondent Contact JAMES ERBS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/29/1999
Decision Date 05/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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