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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K942275
Device Name VIAL VENT FILTER
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 Number880.5440
Classification Product Code
FPB  
Date Received05/10/1994
Decision Date 07/26/1994
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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