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510(k) K850758

AMNIGLOVE & AMNICOT by Go Medical Industries Pty. , Ltd. — Product Code HGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1985
Date Received
February 25, 1985
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

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  • K900336 — V SET (October 4, 1990)
  • K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (October 6, 1989)
  • K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI) (September 12, 1989)
  • K891465 — OBSTETRIC CUP (MODIFICATION) (May 11, 1989)
  • K885283 — ASPIRATING AND IRRIGATING CYSTS NEEDLES (March 22, 1989)
  • K840008 — O'NEIL OBSTETRIC CUP (April 25, 1984)

Other clearances for product code HGE

  • K951148 — OBSTI-HOOK (June 9, 1995)
  • K926425 — AMNIPERF(TM) (March 7, 1994)
  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K834177 — H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 (December 27, 1983)