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FDA 510(k)

BONE GRAFT HARVESTER

K-Number: K973560 · 1997-11-12

ApplicantDs Mfg., Inc.
Decision Date1997-11-12
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE GRAFT HARVESTER is the device name listed in this FDA 510(k) record. The listed applicant is Ds Mfg., Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K973560. 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 BONE GRAFT HARVESTER?

BONE GRAFT HARVESTER is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Ds Mfg., Inc.. The 510(k) number is K973560.

When did BONE GRAFT HARVESTER receive FDA 510(k) clearance?

BONE GRAFT HARVESTER received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973560.

Who is the listed applicant for BONE GRAFT HARVESTER?

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

What is the FDA product code for BONE GRAFT HARVESTER?

The FDA product code for BONE GRAFT HARVESTER is HWE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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