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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 K941032
Device Name UNKNOWN
Applicant
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact MITCHELL L EHRLICH
Correspondent
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact MITCHELL L EHRLICH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/07/1994
Decision Date 05/27/1994
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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