FDA 510(k)

ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO

K-Number: K850012 · 1985-04-22

Decision Date1985-04-22

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO is the device name listed in this FDA 510(k) record. The listed applicant is Heyltex Corp.. It received FDA 510(k) clearance on 1985-04-22 under 510(k) number K850012. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO?

ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Heyltex Corp.. The 510(k) number is K850012.

When did ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO receive FDA 510(k) clearance?

ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO received FDA 510(k) clearance on 1985-04-22, under 510(k) number K850012.

Who is the listed applicant for ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO?

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

What is the FDA product code for ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO?

The FDA product code for ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO is LYC.

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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.