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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 K852996
Device Name DYNA GARD SYRINGE FILTER
Applicant
Microgon, Inc.
23152 Verdugo Dr.
Laguna Hills,  CA  92653
Applicant Contact JAMES J CRONIN
Correspondent
Microgon, Inc.
23152 Verdugo Dr.
Laguna Hills,  CA  92653
Correspondent Contact JAMES J CRONIN
Regulation Number880.5440
Classification Product Code
FPB  
Date Received07/15/1985
Decision Date 09/19/1985
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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