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FDA 510(k)

UNITOX BOTOX SYRINGE

K-Number: K123710 · 2013-05-09

ApplicantBio-Med USA, Inc.
Decision Date2013-05-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNITOX BOTOX SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2013-05-09 under 510(k) number K123710. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITOX BOTOX SYRINGE?

UNITOX BOTOX SYRINGE is a medical device that received FDA 510(k) clearance on 2013-05-09. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K123710.

When did UNITOX BOTOX SYRINGE receive FDA 510(k) clearance?

UNITOX BOTOX SYRINGE received FDA 510(k) clearance on 2013-05-09, under 510(k) number K123710.

Who is the listed applicant for UNITOX BOTOX SYRINGE?

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

What is the FDA product code for UNITOX BOTOX SYRINGE?

The FDA product code for UNITOX BOTOX SYRINGE is FMF.

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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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