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FDA 510(k)

HAMMERLOCK

K-Number: K091951 · 2010-02-19

ApplicantBiomedical Ent., Inc.
Decision Date2010-02-19
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAMMERLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Ent., Inc.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K091951. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAMMERLOCK?

HAMMERLOCK is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Biomedical Ent., Inc.. The 510(k) number is K091951.

When did HAMMERLOCK receive FDA 510(k) clearance?

HAMMERLOCK received FDA 510(k) clearance on 2010-02-19, under 510(k) number K091951.

Who is the listed applicant for HAMMERLOCK?

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

What is the FDA product code for HAMMERLOCK?

The FDA product code for HAMMERLOCK is HTY.

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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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