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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 K896722
Device Name PISTON SYRINGE
Applicant
Safe Tech Medical Products, Inc.
4201 Fm 1960 W Suite 310
Houston,  TX  77068
Applicant Contact MICHAEL L HAINING
Correspondent
Safe Tech Medical Products, Inc.
4201 Fm 1960 W Suite 310
Houston,  TX  77068
Correspondent Contact MICHAEL L HAINING
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/28/1989
Decision Date 01/24/1990
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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