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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K892665
Device Name PRO-JECT(TM) SAFETY NEEDLE HOLDER
Applicant
Pro-Tec Containers, Inc.
3 Morgan #D
Irvine,  CA  92718
Applicant Contact RALPH T HAGINS
Correspondent
Pro-Tec Containers, Inc.
3 Morgan #D
Irvine,  CA  92718
Correspondent Contact RALPH T HAGINS
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/13/1989
Decision Date 10/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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