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FDA 510(k)

MICROBLADE SHAVER AND ACCESSORIES

K-Number: K063231 · 2007-04-16

ApplicantBaxano, Inc.
Decision Date2007-04-16
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROBLADE SHAVER AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Baxano, Inc.. It received FDA 510(k) clearance on 2007-04-16 under 510(k) number K063231. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROBLADE SHAVER AND ACCESSORIES?

MICROBLADE SHAVER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-04-16. The listed applicant is Baxano, Inc.. The 510(k) number is K063231.

When did MICROBLADE SHAVER AND ACCESSORIES receive FDA 510(k) clearance?

MICROBLADE SHAVER AND ACCESSORIES received FDA 510(k) clearance on 2007-04-16, under 510(k) number K063231.

Who is the listed applicant for MICROBLADE SHAVER AND ACCESSORIES?

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

What is the FDA product code for MICROBLADE SHAVER AND ACCESSORIES?

The FDA product code for MICROBLADE SHAVER AND ACCESSORIES is HAE.

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Other records listing Baxano, Inc. as applicant

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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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