FDA 510(k)

MAYFIELD CHILD DISPOSABLE SKULL PIN

K-Number: K941558 · 1995-12-06

ApplicantOhio Medical Instrument Co., Inc.

Decision Date1995-12-06

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MAYFIELD CHILD DISPOSABLE SKULL PIN is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K941558. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD CHILD DISPOSABLE SKULL PIN?

MAYFIELD CHILD DISPOSABLE SKULL PIN is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K941558.

When did MAYFIELD CHILD DISPOSABLE SKULL PIN receive FDA 510(k) clearance?

MAYFIELD CHILD DISPOSABLE SKULL PIN received FDA 510(k) clearance on 1995-12-06, under 510(k) number K941558.

Who is the listed applicant for MAYFIELD CHILD DISPOSABLE SKULL PIN?

The FDA 510(k) record lists Ohio Medical Instrument Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAYFIELD CHILD DISPOSABLE SKULL PIN?

The FDA product code for MAYFIELD CHILD DISPOSABLE SKULL PIN is HBL.

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Other records listing Ohio Medical Instrument Co., Inc. as applicant

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM K992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F K991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A K983282OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 K982244MAYFIELD ACCISS OPTICAL SYSTEM

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Related Devices (Code: HBL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.