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510(k) K822015

BINOCULAR OPERATING MICROSCOPES AND by Kelleher Corp. — Product Code FSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
July 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Kelleher Corp.

  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
  • K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
  • K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
  • K822259 — LARYNGEAL SPATULAS (October 22, 1982)
  • K822004 — FACE SHIELDS (October 20, 1982)

Other clearances for product code FSO

  • K942304 — MICROFLEX (June 13, 1994)
  • K941399 — OPERATING MICROSCOPE AA OM 10 (April 22, 1994)
  • K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (November 12, 1993)
  • K926288 — SOM 6VI (SURGICAL OPERATING MICROSCOPE) (October 12, 1993)
  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K926513 — MOLLER-WEDEL OPERATING MICROSCOPE (June 22, 1993)
  • K910357 — SOM 6V (February 19, 1991)
  • K902076 — J2 MICROSCOPE (August 1, 1990)
  • K874241 — OPMI MD SURGICAL MICROSCOPE (December 23, 1987)
  • K822562 — ODONTO-SCOPE (October 6, 1982)