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510(k) K852329

STAND, OPERATING ROOM by Scholten Surgical Instruments, Inc. — Product Code FOX

K852329 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "STAND, OPERATING ROOM". The FDA issued a decision of Substantially Equivalent on June 14, 1985. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1985
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type

Other clearances by Scholten Surgical Instruments, Inc.

  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (August 1, 1986)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)
  • K852330 — RETRACTOR, SURGICAL (June 27, 1985)

Other clearances for product code FOX

  • K980336 — IV STANDS (April 6, 1998)
  • K964782 — MEDRAD CONTRAST HOLDER (February 25, 1997)
  • K961470 — PORT-A-POLE (July 22, 1996)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 1996)
  • K952196 — IV POLE/STAND (July 31, 1995)
  • K950367 — IV SHUTTLE (April 26, 1995)
  • K946201 — STAND, INFUSION (April 18, 1995)
  • K944580 — FLEXSYS MOBILEMATE EQUIPMENT STAND (March 17, 1995)
  • K932498 — MOBILE CARE IV STAND (October 27, 1993)
  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)

FDA data resources