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510(k) K852331

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC by Scholten Surgical Instruments, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Scholten Surgical Instruments, Inc.

  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852330 — RETRACTOR, SURGICAL (June 27, 1985)
  • K852329 — STAND, OPERATING ROOM (June 14, 1985)

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