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510(k) K921871

HYSTEROMAT(TM) 3700 by F.M. Wiest USA, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
April 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by F.M. Wiest USA, Inc.

  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K920575 — MERKUR 4000 (July 23, 1992)
  • K915751 — URETEROMAT 4400 (April 24, 1992)
  • K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
  • K912071 — SPACE(TM) 7500 (July 9, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)
  • K865066 — ARTHROFLATOR (April 20, 1987)

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