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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 K910731
Device Name DISPOSABLE RETRACTABLE NEEDLE SYRINGE
Applicant
Safe Tech Medical Products, Inc.
6731 Ashmore Dr.
Houston,  TX  77069
Applicant Contact MICHAEL L HAINING
Correspondent
Safe Tech Medical Products, Inc.
6731 Ashmore Dr.
Houston,  TX  77069
Correspondent Contact MICHAEL L HAINING
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/20/1991
Decision Date 05/07/1991
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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