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510(k) K013428

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM by Ohio Medical Instrument Co., Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2002
Date Received
October 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Ohio Medical Instrument Co., Inc.

  • K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (July 29, 2002)
  • K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / (November 2, 1999)
  • K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYST (July 12, 1999)
  • K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 (November 19, 1998)
  • K982244 — MAYFIELD ACCISS OPTICAL SYSTEM (September 23, 1998)
  • K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 (May 17, 1996)
  • K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (February 9, 1996)
  • K941558 — MAYFIELD CHILD DISPOSABLE SKULL PIN (December 6, 1995)
  • K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP (January 7, 1994)
  • K932860 — MAYFIELD ADULT DISPOSABLE SKULL PIN (September 28, 1993)

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