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FDA 510(k)

SUTURING WASHER

K-Number: K052642 · 2006-01-17

ApplicantFirst Call, Inc.
Decision Date2006-01-17
Product CodeMAB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUTURING WASHER is the device name listed in this FDA 510(k) record. The listed applicant is First Call, Inc.. It received FDA 510(k) clearance on 2006-01-17 under 510(k) number K052642. The device is classified under product code MAB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURING WASHER?

SUTURING WASHER is a medical device that received FDA 510(k) clearance on 2006-01-17. The listed applicant is First Call, Inc.. The 510(k) number is K052642.

When did SUTURING WASHER receive FDA 510(k) clearance?

SUTURING WASHER received FDA 510(k) clearance on 2006-01-17, under 510(k) number K052642.

Who is the listed applicant for SUTURING WASHER?

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

What is the FDA product code for SUTURING WASHER?

The FDA product code for SUTURING WASHER is MAB.

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Related Devices (Code: MAB)

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.

K001915GRAFT MARKER RINGT. Korossurgical Instruments Corp.K894268C.A.B. RINGMedi-Sharp, 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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