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510(k) K922288

HOLDER, PEDIATRIC POSITION by Yamashita and Hemsley Business Trust — Product Code BWN

K922288 is an FDA 510(k) premarket notification submitted by Yamashita and Hemsley Business Trust for the device "HOLDER, PEDIATRIC POSITION". The FDA issued a decision of Substantially Equivalent on February 10, 1993. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1993
Date Received
May 15, 1992
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

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

FDA data resources