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FDA 510(k)

DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT

K-Number: K930586 · 1993-12-17

ApplicantDavis & Geck, Inc.
Decision Date1993-12-17
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT 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 1993-12-17 under 510(k) number K930586. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT?

DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K930586.

When did DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT receive FDA 510(k) clearance?

DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT received FDA 510(k) clearance on 1993-12-17, under 510(k) number K930586.

Who is the listed applicant for DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT?

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 DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT?

The FDA product code for DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT is GAR.

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Other records listing Davis & Geck, 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.

K982853SILK SUTUREK981582SURGILON, DERMALON, & OPHTHALONK980610DEXON RAPID (DEXON R)K974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRALK980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICEK973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS

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Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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