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FDA 510(k)

SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC

K-Number: K930738 · 1994-07-26

ApplicantDeknatel, Inc.
Decision Date1994-07-26
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K930738. 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 SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC?

SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Deknatel, Inc.. The 510(k) number is K930738.

When did SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC receive FDA 510(k) clearance?

SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC received FDA 510(k) clearance on 1994-07-26, under 510(k) number K930738.

Who is the listed applicant for SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC?

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

What is the FDA product code for SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC?

The FDA product code for SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC is GAL.

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Other records listing Deknatel, 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.

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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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