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510(k) K822427

SELF-CONTAINED MOBILE OPHTHAL. OPER. . by Surgi-Quip Inc.U — Product Code FSE

K822427 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "SELF-CONTAINED MOBILE OPHTHAL. OPER. .". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Surgi-Quip Inc.U

  • K841116 — MOBILE OPHTHALMIC OPERATING TABLE (May 9, 1984)
  • K841115 — CHARLES/MCINTYRE GIANT BREAK TABLE (May 9, 1984)
  • K840004 — WEE BAG O'MERCURY (March 22, 1984)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K822554 — CEMENT EXTRACTION INSTRUMENTATION (September 14, 1982)
  • K822428 — SURGI-QUIP MICROSCOPE STAND (September 2, 1982)
  • K822426 — MCINTYRE MICROSCOPE STAND (September 2, 1982)

Other clearances for product code FSE

  • K860503 — THE POREX RETRACTOR TABLE (March 13, 1986)
  • K843801 — MASON EQUIPMENT ORGANIZER & ASPEN (October 25, 1984)
  • K840027 — OPERATING ROOM STAND (February 4, 1984)
  • K831042 — CHEMONUCLEOLYSIS TABLE EXTENSION (May 16, 1983)
  • K830339 — IMSI/METRIPOND HAND OPERATING TABLE (April 12, 1983)
  • K821924 — TABLE, OPERATING, FIELD 6530-00-709-8155 (July 13, 1982)
  • K801382 — DISPOSABLE SURGICAL HEAD SUPPORT (June 26, 1980)
  • K782092 — ARMBOARD CVER, DISPOSABLE (January 10, 1979)
  • K780866 — CHEST ROLLS HOLDER (August 14, 1978)
  • K780868 — CHEST ROLLS (August 14, 1978)

FDA data resources