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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 K901508
Device Name RETRAX SAFETY SYRINGE
Applicant
Retrax, Inc.
444 Holderieth
Tomball,  TX  77375
Applicant Contact WALTER W GLOYER
Correspondent
Retrax, Inc.
444 Holderieth
Tomball,  TX  77375
Correspondent Contact WALTER W GLOYER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/30/1990
Decision Date 06/14/1990
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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