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510(k) K972426

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH by Imagyn Medical, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1997
Date Received
June 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Imagyn Medical, Inc.

  • K970750 — MICROSPAN INSEMINATION SYSTEM (May 5, 1997)
  • K971255 — IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (April 21, 1997)
  • K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (March 6, 1997)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K961688 — MICROSPAN HYSTEROSCOPE (October 15, 1996)
  • K961506 — MICROSPAN HYSTEROSCOPE SHEATH (July 3, 1996)
  • K952032 — IMAGYN HYSTEROSCOPE SHEATHS (October 31, 1995)
  • K951996 — IMAGYN ENDOSCOPE (September 1, 1995)
  • K951974 — IMAGYN ENDOSCOPE SHEATH (August 28, 1995)
  • K953201 — IMAGYN UROSCOPE (August 2, 1995)

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