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510(k) K910518

GLOVE-N-GEL AMNIOTOMY KIT by Epcom Medical Systems, Inc. — Product Code HGE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 9, 1991
Date Received
February 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amniotome
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Epcom Medical Systems, Inc.

  • K905812 — INTRAUTERINE CATHETER SET (January 31, 1991)
  • K881414 — CERVICATH (June 14, 1988)
  • K871079 — FETALFLEX FETAL ELECTRODE (July 13, 1987)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (January 2, 1985)
  • K841805 — OBSTETRICAL DOPPLER (June 19, 1984)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)
  • K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTE (June 30, 1983)

Other clearances for product code HGE

  • K951148 — OBSTI-HOOK (June 9, 1995)
  • K926425 — AMNIPERF(TM) (March 7, 1994)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)
  • K834177 — H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 (December 27, 1983)