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FDA 510(k)

AILEE SUTURES AND AILEE NEEDLES

K-Number: K982646 · 1999-06-02

ApplicantMyco Medical Supplies, Inc.
Decision Date1999-06-02
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AILEE SUTURES AND AILEE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Myco Medical Supplies, Inc.. It received FDA 510(k) clearance on 1999-06-02 under 510(k) number K982646. 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 AILEE SUTURES AND AILEE NEEDLES?

AILEE SUTURES AND AILEE NEEDLES is a medical device that received FDA 510(k) clearance on 1999-06-02. The listed applicant is Myco Medical Supplies, Inc.. The 510(k) number is K982646.

When did AILEE SUTURES AND AILEE NEEDLES receive FDA 510(k) clearance?

AILEE SUTURES AND AILEE NEEDLES received FDA 510(k) clearance on 1999-06-02, under 510(k) number K982646.

Who is the listed applicant for AILEE SUTURES AND AILEE NEEDLES?

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

What is the FDA product code for AILEE SUTURES AND AILEE NEEDLES?

The FDA product code for AILEE SUTURES AND AILEE NEEDLES is GAL.

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Other records listing Myco Medical Supplies, Inc. as applicant

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K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal NeedlesK173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderK090426VAKU-8 BLOOD COLLECTION NEEDLESK042504CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETERK000592UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SETK990519PHOENIX EPIDURAL & SPINAL NEEDLES

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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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