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510(k) K940316

HYSTERSCOPE by Stephen Chakoff, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
January 24, 1994
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 Stephen Chakoff, Inc.

  • K940317 — SINUSCOPE (May 24, 1995)
  • K950753 — CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO (May 15, 1995)
  • K951082 — CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE (March 22, 1995)
  • K950744 — CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) (March 6, 1995)
  • K950748 — CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) (March 6, 1995)
  • K950747 — CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) (March 6, 1995)
  • K950745 — CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) (March 6, 1995)
  • K950746 — CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) (March 6, 1995)
  • K945421 — CHAKOFF ENDOSCOPY (December 23, 1994)
  • K945420 — CHAKOFF ENDOSCOPY (December 8, 1994)

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