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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 K896086
Device Name PROGUARD II(TM)
Applicant
Safety-Ject, Inc.
535 Anton, Suite 450
Costa Mesa,  CA  92626
Applicant Contact DENNIS SITAR
Correspondent
Safety-Ject, Inc.
535 Anton, Suite 450
Costa Mesa,  CA  92626
Correspondent Contact DENNIS SITAR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/19/1989
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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