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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 K910667
Device Name STERI-STAT REUSABLE SYRINGE
Applicant
David Craig Marketing, Inc.
P.O. Box 89
Martinsville,  NJ  08836
Applicant Contact GEORGE V MASTAPETER
Correspondent
David Craig Marketing, Inc.
P.O. Box 89
Martinsville,  NJ  08836
Correspondent Contact GEORGE V MASTAPETER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/13/1991
Decision Date 09/04/1991
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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