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FDA 510(k)

GRAF MENISCAL SUTURE SET

K-Number: K830720 · 1983-06-16

ApplicantAcufex Microsurgical, Inc.
Decision Date1983-06-16
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAF MENISCAL SUTURE SET is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K830720. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAF MENISCAL SUTURE SET?

GRAF MENISCAL SUTURE SET is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K830720.

When did GRAF MENISCAL SUTURE SET receive FDA 510(k) clearance?

GRAF MENISCAL SUTURE SET received FDA 510(k) clearance on 1983-06-16, under 510(k) number K830720.

Who is the listed applicant for GRAF MENISCAL SUTURE SET?

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

What is the FDA product code for GRAF MENISCAL SUTURE SET?

The FDA product code for GRAF MENISCAL SUTURE SET is FZX.

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Other records listing Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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