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FDA 510(k)

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP

K-Number: K000542 · 2000-04-28

ApplicantArc Medical Supplies (Beijing) Co, Ltd.
Decision Date2000-04-28
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP is the device name listed in this FDA 510(k) record. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K000542. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP?

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. The 510(k) number is K000542.

When did PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP receive FDA 510(k) clearance?

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP received FDA 510(k) clearance on 2000-04-28, under 510(k) number K000542.

Who is the listed applicant for PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP?

The FDA 510(k) record lists Arc Medical Supplies (Beijing) Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP?

The FDA product code for PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP is GAL.

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Other records listing Arc Medical Supplies (Beijing) Co, Ltd. 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.

K022666PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.K022664PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.K000541SILK NONABSORBABLE SURGICAL SUTURES, USPK000537POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USPK000539NYLON NONABSORBABLE SURGICAL SUTURES, USPK000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

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Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC

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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