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FDA 510(k)

ACE ORTHOPAEDIC WASHERS

K-Number: K895107 · 1989-09-11

ApplicantBuckman Co., Inc.
Decision Date1989-09-11
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE ORTHOPAEDIC WASHERS is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1989-09-11 under 510(k) number K895107. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE ORTHOPAEDIC WASHERS?

ACE ORTHOPAEDIC WASHERS is a medical device that received FDA 510(k) clearance on 1989-09-11. The listed applicant is Buckman Co., Inc.. The 510(k) number is K895107.

When did ACE ORTHOPAEDIC WASHERS receive FDA 510(k) clearance?

ACE ORTHOPAEDIC WASHERS received FDA 510(k) clearance on 1989-09-11, under 510(k) number K895107.

Who is the listed applicant for ACE ORTHOPAEDIC WASHERS?

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

What is the FDA product code for ACE ORTHOPAEDIC WASHERS?

The FDA product code for ACE ORTHOPAEDIC WASHERS is HTN.

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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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