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FDA 510(k)

LM15(TM), CATALOG NUMBER - 523821

K-Number: K914690 · 1992-03-23

ApplicantEdward Weck, Inc.
Decision Date1992-03-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LM15(TM), CATALOG NUMBER - 523821 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 1992-03-23 under 510(k) number K914690. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM15(TM), CATALOG NUMBER - 523821?

LM15(TM), CATALOG NUMBER - 523821 is a medical device that received FDA 510(k) clearance on 1992-03-23. The listed applicant is Edward Weck, Inc.. The 510(k) number is K914690.

When did LM15(TM), CATALOG NUMBER - 523821 receive FDA 510(k) clearance?

LM15(TM), CATALOG NUMBER - 523821 received FDA 510(k) clearance on 1992-03-23, under 510(k) number K914690.

Who is the listed applicant for LM15(TM), CATALOG NUMBER - 523821?

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 LM15(TM), CATALOG NUMBER - 523821?

The FDA product code for LM15(TM), CATALOG NUMBER - 523821 is GCJ.

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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 TROCARK911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)K902232WECK ELECTROSURGICAL GENERATOR #174200

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Related Devices (Code: GCJ)

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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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