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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K904295
Device Name PROGUARD(TM) BLOOD COLLECTION NEEDLE
Applicant
Safety-Ject, Inc.
10400 Trademark St.
Rancho Cucamonga,  CA  91730
Applicant Contact ROBERT J BARD
Correspondent
Safety-Ject, Inc.
10400 Trademark St.
Rancho Cucamonga,  CA  91730
Correspondent Contact ROBERT J BARD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/19/1990
Decision Date 10/15/1990
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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