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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 K950012
Device Name DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES
Applicant
International Regulatory Consultants
141-12 73rd Terr.
Flushing,  NY  11367
Applicant Contact ELI M ORBACH
Correspondent
International Regulatory Consultants
141-12 73rd Terr.
Flushing,  NY  11367
Correspondent Contact ELI M ORBACH
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/03/1995
Decision Date 08/18/1995
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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