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510(k) K830339

IMSI/METRIPOND HAND OPERATING TABLE by Intl. Management Services, Inc. — Product Code FSE

K830339 is an FDA 510(k) premarket notification submitted by Intl. Management Services, Inc. for the device "IMSI/METRIPOND HAND OPERATING TABLE". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Intl. Management Services, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
February 1, 1983
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 Intl. Management Services, Inc.

  • K873612 — IMSI, VITAL CALL (November 23, 1987)
  • K872876 — IMSI/EASY FLOAT MATTRESS (October 13, 1987)
  • K843370 — IMSI/METRIPOND GRIPPER PLATE (January 23, 1985)

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)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 1982)
  • 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)
  • K780868 — CHEST ROLLS (August 14, 1978)
  • K780867 — PAD HOLDER KIT (August 14, 1978)

FDA data resources