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510(k) K780868

CHEST ROLLS by Devon Industries, Inc. — Product Code FSE

K780868 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "CHEST ROLLS". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
May 30, 1978
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 Devon Industries, Inc.

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE (July 10, 1995)
  • K944114 — PHLEBOTOMY UNIT SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K932998 — EASY-ON (August 18, 1993)
  • K912824 — DEVON SPONGE COUNTER BAGS (August 26, 1991)
  • K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER (September 7, 1989)

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)
  • 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)
  • K780867 — PAD HOLDER KIT (August 14, 1978)

FDA data resources