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FDA 510(k)

REPROCESSED SOFT TISSUE ABLATORS

K-Number: K012631 · 2001-12-06

ApplicantAlliance Medical Corp.
Decision Date2001-12-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED SOFT TISSUE ABLATORS is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2001-12-06 under 510(k) number K012631. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED SOFT TISSUE ABLATORS?

REPROCESSED SOFT TISSUE ABLATORS is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Alliance Medical Corp.. The 510(k) number is K012631.

When did REPROCESSED SOFT TISSUE ABLATORS receive FDA 510(k) clearance?

REPROCESSED SOFT TISSUE ABLATORS received FDA 510(k) clearance on 2001-12-06, under 510(k) number K012631.

Who is the listed applicant for REPROCESSED SOFT TISSUE ABLATORS?

The FDA 510(k) record lists Alliance Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED SOFT TISSUE ABLATORS?

The FDA product code for REPROCESSED SOFT TISSUE ABLATORS is GEI.

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Other records listing Alliance Medical Corp. 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.

K060648REPROCESSED PHACOEMULSIFICATION TIPSK061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSK060049REPROCESSED COMPRESSION SLEEVESK060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESK053316REPROCESSED COMPRESSION SLEEVESK052918REPROCESSED EXTERNAL FIXATION DEVICES

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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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