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510(k) K951148

OBSTI-HOOK by Onli — Product Code HGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
March 13, 1995
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 for product code HGE

  • K926425 — AMNIPERF(TM) (March 7, 1994)
  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • 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)