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FDA 510(k)

ALLPORT MASTOID RETRACTORS

K-Number: K772392 · 1978-01-17

ApplicantEdward Weck, Inc.
Decision Date1978-01-17
Product CodeKAL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ALLPORT MASTOID RETRACTORS is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1978-01-17 under 510(k) number K772392. 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 ALLPORT MASTOID RETRACTORS?

ALLPORT MASTOID RETRACTORS is a medical device that received FDA 510(k) clearance on 1978-01-17. The listed applicant is Edward Weck, Inc.. The 510(k) number is K772392.

When did ALLPORT MASTOID RETRACTORS receive FDA 510(k) clearance?

ALLPORT MASTOID RETRACTORS received FDA 510(k) clearance on 1978-01-17, under 510(k) number K772392.

Who is the listed applicant for ALLPORT MASTOID RETRACTORS?

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

What is the FDA product code for ALLPORT MASTOID RETRACTORS?

The FDA product code for ALLPORT MASTOID RETRACTORS is KAL.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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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.

K870758SMALL MASTOID RETRACTORTreace Medical, Inc.K833604ADJUSTABLE FORK RETRACTORMicrotek Medical, Inc.K772381RING HANDLE & 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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