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FDA 510(k)

ULNAR-RADIAL APPROXIMATER

K-Number: K780291 · 1978-02-28

ApplicantEdward Weck, Inc.
Decision Date1978-02-28
Product CodeGDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULNAR-RADIAL APPROXIMATER 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 1978-02-28 under 510(k) number K780291. The device is classified under product code GDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULNAR-RADIAL APPROXIMATER?

ULNAR-RADIAL APPROXIMATER is a medical device that received FDA 510(k) clearance on 1978-02-28. The listed applicant is Edward Weck, Inc.. The 510(k) number is K780291.

When did ULNAR-RADIAL APPROXIMATER receive FDA 510(k) clearance?

ULNAR-RADIAL APPROXIMATER received FDA 510(k) clearance on 1978-02-28, under 510(k) number K780291.

Who is the listed applicant for ULNAR-RADIAL APPROXIMATER?

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 ULNAR-RADIAL APPROXIMATER?

The FDA product code for ULNAR-RADIAL APPROXIMATER is GDJ.

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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: GDJ)

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.

K153358Standard ClampStandard BariatricsK930315THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCEThomasville Medical Assoc.K924223MAR-MED LIVER STRAPMar-Med Co.K922659GENERAL SURGERY CLAMP AND NEEDLE HOLDERMiltex Instrument Co.K914913GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYSTIdeal Medical, Inc.K900956GS-7100 CHOLANGIOGRAM CLAMP, 5MMSolos Endoscopy, Inc.

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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