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510(k) K902865

BAUMER SURGICAL TABLE by Sds Dental, Inc. — Product Code BWN

K902865 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "BAUMER SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on September 10, 1990. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1990
Date Received
June 29, 1990
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 Sds Dental, Inc.

  • K990546 — DELSONIC 2000 (November 5, 1999)
  • K990545 — JETSONIC 2000 (August 11, 1999)
  • K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (January 22, 1997)
  • K902864 — SURGICAL LIGHTING-CENTRA 450 (September 10, 1990)
  • K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II (October 10, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863013 — ISOLAX PEDAL SET (October 1, 1986)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863021 — CM-II, CM-I WATER UNIT (October 1, 1986)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)

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)
  • 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)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)

FDA data resources