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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 K931472
Device Name CAREJECT DISPOSABLE SYRINGE AND NEEDLE
Applicant
Carewell Mediproducts, Ltd.
502 Mansarovar, 90 Nehru Pl.
New Delhi,  IN 110019
Applicant Contact NAND
Correspondent
Carewell Mediproducts, Ltd.
502 Mansarovar, 90 Nehru Pl.
New Delhi,  IN 110019
Correspondent Contact NAND
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/24/1993
Decision Date 02/22/1994
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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