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510(k) K821924

TABLE, OPERATING, FIELD 6530-00-709-8155 by Emerson-Sack-Warner Corp. — Product Code FSE

K821924 is an FDA 510(k) premarket notification submitted by Emerson-Sack-Warner Corp. for the device "TABLE, OPERATING, FIELD 6530-00-709-8155". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Emerson-Sack-Warner Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
June 29, 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 Emerson-Sack-Warner Corp.

  • K821921 — STAND, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K821927 — TABLE, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K821923 — TABLE, OPERATING, FIELD 6530-00-709-8175 (July 13, 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)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 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