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FDA 510(k)

ABSORBALBE ANCHOR

K-Number: K944051 · 1995-08-02

ApplicantMitek Surgical Products, Inc.
Decision Date1995-08-02
Product CodeMNV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ABSORBALBE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-08-02 under 510(k) number K944051. The device is classified under product code MNV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABSORBALBE ANCHOR?

ABSORBALBE ANCHOR is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K944051.

When did ABSORBALBE ANCHOR receive FDA 510(k) clearance?

ABSORBALBE ANCHOR received FDA 510(k) clearance on 1995-08-02, under 510(k) number K944051.

Who is the listed applicant for ABSORBALBE ANCHOR?

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

What is the FDA product code for ABSORBALBE ANCHOR?

The FDA product code for ABSORBALBE ANCHOR is MNV.

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Other records listing Mitek Surgical Products, 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.

K953560MITEK THREADED ANCHOR (FASTIN)K953877MITEK GII ANCHORK936311MITEK MINI ANCHORK941599MITEK ABSORBABLE ANCHORK950070MITEK TOGGLE ANCHOR(TM)K944936MITEK G III ANCHOR, MITEK LS ANCHOR

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Related Devices (Code: MNV)

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.

K101750RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104Reprocessing Products CorpK031267STERICHEK BICARB PH REAGENT STRIPSEnvironmental Test Systems, Inc.K936311MITEK MINI ANCHORMitek Surgical Products, Inc.K941599MITEK ABSORBABLE ANCHORMitek Surgical Products, Inc.K945491SERIM(TM) BICARB PH REAGENT STRIPSSerim Research 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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