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510(k) K832340

OPERATING ROOM TABLES HYDRAULIC by Kamiya Tsusan Kaisha, Ltd. — Product Code BWN

K832340 is an FDA 510(k) premarket notification submitted by Kamiya Tsusan Kaisha, Ltd. for the device "OPERATING ROOM TABLES HYDRAULIC". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Kamiya Tsusan Kaisha, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Kamiya Tsusan Kaisha, Ltd.

  • K863161 — TABLE, OPERATING ROOM, HYDRAULIC (September 5, 1986)
  • K832341 — ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC (October 4, 1983)
  • K832342 — ENDOSCOPIC CAMERA TV W/AUDIO (September 12, 1983)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)

FDA data resources