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510(k) K911844

HYSTEROFLATOR 1500 by F.M. Wiest USA, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1991
Date Received
April 25, 1991
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.

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  • K915751 — URETEROMAT 4400 (April 24, 1992)
  • K912071 — SPACE(TM) 7500 (July 9, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K865066 — ARTHROFLATOR (April 20, 1987)

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