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510(k) K792569

OPERATING TABLES & AMPLINOX 03 by Ets Rene Marzet — Product Code BWN

K792569 is an FDA 510(k) premarket notification submitted by Ets Rene Marzet for the device "OPERATING TABLES & AMPLINOX 03". The FDA issued a decision of Substantially Equivalent on January 4, 1980. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Ets Rene Marzet has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1980
Date Received
December 13, 1979
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 Ets Rene Marzet

  • K792568 — OBSTETRICAL BEDS (January 28, 1980)
  • K792570 — PATIENT TROLLEY B49 (December 31, 1979)

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