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510(k) K910357

SOM 6V by Jedmed Instrument Co. — Product Code FSO

K910357 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "SOM 6V". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code FSO (Microscope, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4700. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
January 29, 1991
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 Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)

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)
  • K902076 — J2 MICROSCOPE (August 1, 1990)
  • K874241 — OPMI MD SURGICAL MICROSCOPE (December 23, 1987)
  • K822562 — ODONTO-SCOPE (October 6, 1982)
  • K822181 — BINOCULAR OPER. MICROSCOPES & ACCESSOR (August 27, 1982)

FDA data resources