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FDA 510(k)

SMALL MASTOID RETRACTOR

K-Number: K870758 · 1987-03-04

ApplicantTreace Medical, Inc.
Decision Date1987-03-04
Product CodeKAL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SMALL MASTOID RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1987-03-04 under 510(k) number K870758. The device is classified under product code KAL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMALL MASTOID RETRACTOR?

SMALL MASTOID RETRACTOR is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Treace Medical, Inc.. The 510(k) number is K870758.

When did SMALL MASTOID RETRACTOR receive FDA 510(k) clearance?

SMALL MASTOID RETRACTOR received FDA 510(k) clearance on 1987-03-04, under 510(k) number K870758.

Who is the listed applicant for SMALL MASTOID RETRACTOR?

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

What is the FDA product code for SMALL MASTOID RETRACTOR?

The FDA product code for SMALL MASTOID RETRACTOR is KAL.

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Other records listing Treace 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: KAL)

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.

K833604ADJUSTABLE FORK RETRACTORMicrotek Medical, Inc.K772381RING HANDLE & RETRACTORSEdward Weck, Inc.K772392ALLPORT MASTOID RETRACTORSEdward Weck, Inc.K760851CONVERSE ALTAR RETRACTORV. Mueller O.V. Baxter Healthcare Corp.

Official Source

View on FDA Database →

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

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