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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 K844796
Device Name MICRO-BETA U100 SYRINGE
Applicant
Orange Medical Instruments, Inc.
3183 Airway Ave.
Suite F
Costa Mesa,  CA  92626
Applicant Contact HELENE EHRLICH
Correspondent
Orange Medical Instruments, Inc.
3183 Airway Ave.
Suite F
Costa Mesa,  CA  92626
Correspondent Contact HELENE EHRLICH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/11/1984
Decision Date 12/18/1984
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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