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FDA 510(k)

PROMEX ENT TISSUE REMOVAL SYSTEM

K-Number: K972865 · 1997-09-29

ApplicantPromex, Inc.
Decision Date1997-09-29
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROMEX ENT TISSUE REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K972865. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMEX ENT TISSUE REMOVAL SYSTEM?

PROMEX ENT TISSUE REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Promex, Inc.. The 510(k) number is K972865.

When did PROMEX ENT TISSUE REMOVAL SYSTEM receive FDA 510(k) clearance?

PROMEX ENT TISSUE REMOVAL SYSTEM received FDA 510(k) clearance on 1997-09-29, under 510(k) number K972865.

Who is the listed applicant for PROMEX ENT TISSUE REMOVAL SYSTEM?

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

What is the FDA product code for PROMEX ENT TISSUE REMOVAL SYSTEM?

The FDA product code for PROMEX ENT TISSUE REMOVAL SYSTEM is ERL.

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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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