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510(k) K862717

HAND MIRROR (ENDOSCOPE) by Simpson/Basye, Inc. — Product Code GCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1986
Date Received
July 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Mirror
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Simpson/Basye, Inc.

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  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (March 29, 1989)
  • K891347 — REID ENDOCERVICAL SPREADER (March 29, 1989)
  • K891349 — CAMPION CERVICAL HOOK (March 29, 1989)
  • K891348 — CAMPION LASER FORCEPS (March 22, 1989)
  • K870276 — HEATED INSTRUMENT BATH (May 7, 1987)
  • K862629 — SURGICAL LASER ACCESSORIES (SLA) CASE (July 17, 1986)
  • K790923 — MI-MARK ENDOCERVICAL SAMPLING SET (June 22, 1979)

Other clearances for product code GCO

  • K862838 — CYTOTECH HSV IGG ENZYME IMMUNOASSAY (December 9, 1986)
  • K790340 — DELTA-ROL (April 12, 1979)