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FDA 510(k)

DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT

K-Number: K072930 · 2008-04-30

ApplicantDemetech Corp.
Decision Date2008-04-30
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corp.. It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K072930. 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 DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT?

DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Demetech Corp.. The 510(k) number is K072930.

When did DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT receive FDA 510(k) clearance?

DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT received FDA 510(k) clearance on 2008-04-30, under 510(k) number K072930.

Who is the listed applicant for DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT?

The FDA 510(k) record lists Demetech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT?

The FDA product code for DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT is GAL.

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Other records listing Demetech Corp. 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.

K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREK082097DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTUREK043330POLYPROPILENE SURGICAL SUTURESK043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESK023030DEMETECH POLYESTER NONABSORBABLE SUTUREK023028DEMETECH NYLON NONABSORBABLE SUTURE

View all 8 devices →

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.

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, LLCK011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting

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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