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FDA 510(k)

MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY

K-Number: K820852 · 1982-04-15

ApplicantSerrano Intl.
Decision Date1982-04-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY is the device name listed in this FDA 510(k) record. The listed applicant is Serrano Intl.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820852. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY?

MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Serrano Intl.. The 510(k) number is K820852.

When did MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY receive FDA 510(k) clearance?

MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820852.

Who is the listed applicant for MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY?

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

What is the FDA product code for MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY?

The FDA product code for MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY is HSB.

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Other records listing Serrano Intl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HSB)

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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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