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510(k) K895034

BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C by Yamato Medical Corp. — Product Code IXY

K895034 is an FDA 510(k) premarket notification submitted by Yamato Medical Corp. for the device "BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C". The FDA issued a decision of Substantially Equivalent on November 15, 1989. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1989
Date Received
August 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances for product code IXY

  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)

FDA data resources