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FDA 510(k)

INTRA-ARTICULAR ARTHROSCOPIC SHAVER

K-Number: K874044 · 1987-10-15

ApplicantMedline Industries, Inc.
Decision Date1987-10-15
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRA-ARTICULAR ARTHROSCOPIC SHAVER is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1987-10-15 under 510(k) number K874044. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ARTICULAR ARTHROSCOPIC SHAVER?

INTRA-ARTICULAR ARTHROSCOPIC SHAVER is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Medline Industries, Inc.. The 510(k) number is K874044.

When did INTRA-ARTICULAR ARTHROSCOPIC SHAVER receive FDA 510(k) clearance?

INTRA-ARTICULAR ARTHROSCOPIC SHAVER received FDA 510(k) clearance on 1987-10-15, under 510(k) number K874044.

Who is the listed applicant for INTRA-ARTICULAR ARTHROSCOPIC SHAVER?

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

What is the FDA product code for INTRA-ARTICULAR ARTHROSCOPIC SHAVER?

The FDA product code for INTRA-ARTICULAR ARTHROSCOPIC SHAVER is HWE.

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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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