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FDA 510(k)

LACTOSORB HAND SYSTEM

K-Number: K991763 · 1999-07-30

ApplicantBiomet, Inc.
Decision Date1999-07-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSORB HAND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991763. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTOSORB HAND SYSTEM?

LACTOSORB HAND SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Biomet, Inc.. The 510(k) number is K991763.

When did LACTOSORB HAND SYSTEM receive FDA 510(k) clearance?

LACTOSORB HAND SYSTEM received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991763.

Who is the listed applicant for LACTOSORB HAND SYSTEM?

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

What is the FDA product code for LACTOSORB HAND SYSTEM?

The FDA product code for LACTOSORB HAND SYSTEM is HRS.

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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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