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510(k) K905495

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR by Frigitronics, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
December 7, 1990
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 Frigitronics, Inc.

  • K905392 — HT4-SERIES HYSTEROSCOPES AND ACCESSORIES (April 30, 1991)
  • K905393 — HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR (January 16, 1991)

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