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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 K911440
Device Name RAPI-JECT(R) SYRINGE
Applicant
David Bull Laboratories, USA, Inc.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Applicant Contact JOHN ROHRBOUGH
Correspondent
David Bull Laboratories, USA, Inc.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Correspondent Contact JOHN ROHRBOUGH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/01/1991
Decision Date 12/30/1991
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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