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FDA 510(k)

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN

K-Number: K915800 · 1992-03-16

ApplicantBremer Medical, Inc.
Decision Date1992-03-16
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN is the device name listed in this FDA 510(k) record. The listed applicant is Bremer Medical, Inc.. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K915800. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN?

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is Bremer Medical, Inc.. The 510(k) number is K915800.

When did BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN receive FDA 510(k) clearance?

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN received FDA 510(k) clearance on 1992-03-16, under 510(k) number K915800.

Who is the listed applicant for BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN?

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

What is the FDA product code for BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN?

The FDA product code for BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN is JEC.

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Other records listing Bremer Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K924606BREMER IMAGING TONGS-MRI MODEL

Related Devices (Code: JEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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