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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, uterine contraction, external (for use in clinic)
510(k) Number K954847
Device Name DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
Applicant
OCG SYSTEMS, INC.
215 PROSPECT AVE.
HIGHLAND PARK,  IL  60035
Applicant Contact FREDRIC I ORKIN
Correspondent
OCG SYSTEMS, INC.
215 PROSPECT AVE.
HIGHLAND PARK,  IL  60035
Correspondent Contact FREDRIC I ORKIN
Regulation Number884.2720
Classification Product Code
HFM  
Date Received10/23/1995
Decision Date 05/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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