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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 K882403
Device Name OPHTHALMIC FLUID INJECTOR
Applicant
Trek Medical Products, Inc.
P.O. Box B, 820 Swan Dr.
Mukwonago,  WI  53149
Applicant Contact KEVIN B SINNETT
Correspondent
Trek Medical Products, Inc.
P.O. Box B, 820 Swan Dr.
Mukwonago,  WI  53149
Correspondent Contact KEVIN B SINNETT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/10/1988
Decision Date 09/09/1988
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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