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FDA 510(k)

ML-810 CARBON DIOXIDE LASER SYSTEM

K-Number: K827442 · 1982-05-19

Decision Date1982-05-19
Product Code
DecisionSubstantially Equivalent

Device Summary

ML-810 CARBON DIOXIDE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Merrimack Laboratories. It received FDA 510(k) clearance on 1982-05-19 under 510(k) number K827442. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ML-810 CARBON DIOXIDE LASER SYSTEM?

ML-810 CARBON DIOXIDE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1982-05-19. The listed applicant is Merrimack Laboratories. The 510(k) number is K827442.

When did ML-810 CARBON DIOXIDE LASER SYSTEM receive FDA 510(k) clearance?

ML-810 CARBON DIOXIDE LASER SYSTEM received FDA 510(k) clearance on 1982-05-19, under 510(k) number K827442.

Who is the listed applicant for ML-810 CARBON DIOXIDE LASER SYSTEM?

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

Related Clinical Trials

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.

Other records listing Merrimack Laboratories 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.

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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