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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 K945284
Device Name TRUJECT
Applicant
Clive Craig Co.
600 E Hueneme Rd.
Oxnard,  CA  93033
Applicant Contact PAUL WITTROCK
Correspondent
Clive Craig Co.
600 E Hueneme Rd.
Oxnard,  CA  93033
Correspondent Contact PAUL WITTROCK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/31/1994
Decision Date 12/29/1994
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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