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510(k) K843801

MASON EQUIPMENT ORGANIZER & ASPEN by Aspen Laboratories, Inc. — Product Code FSE

K843801 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "MASON EQUIPMENT ORGANIZER & ASPEN". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
September 27, 1984
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 Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

Other clearances for product code FSE

  • K860503 — THE POREX RETRACTOR TABLE (March 13, 1986)
  • 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)
  • 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