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FDA 510(k)

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE

K-Number: K951352 · 1995-06-05

ApplicantDavis & Geck, Inc.
Decision Date1995-06-05
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Davis & Geck, Inc.. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K951352. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE?

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K951352.

When did DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE receive FDA 510(k) clearance?

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE received FDA 510(k) clearance on 1995-06-05, under 510(k) number K951352.

Who is the listed applicant for DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE?

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

What is the FDA product code for DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE?

The FDA product code for DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE is GAM.

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Other records listing Davis & Geck, Inc. as applicant

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Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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