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510(k) K881414

CERVICATH by Epcom Medical Systems, Inc. — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1988
Date Received
April 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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  • K841805 — OBSTETRICAL DOPPLER (June 19, 1984)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTE (June 30, 1983)

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