Home / 510(k) Clearances / K810150

510(k) K810150

OMNISURG WORKING INSTRUMENT TABLE by Polamedco, Inc.

K810150 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "OMNISURG WORKING INSTRUMENT TABLE". The FDA issued a decision of Substantially Equivalent on February 12, 1981. Polamedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
January 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Polamedco, Inc.

  • K983000 — CRICOTHYROTOMY TUBE (October 27, 1999)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K953793 — INTROSCOPE (November 29, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K920900 — POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES (March 18, 1992)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)

FDA data resources