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510(k) K021604

MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 by Ohio Medical Instrument Co., Inc. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2002
Date Received
May 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

Other clearances by Ohio Medical Instrument Co., Inc.

  • K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM (April 4, 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)
  • K932807 — MAYFIELD* A-2000 SKULL CLAMP (September 28, 1993)

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