FDA 510(k)

MODEL ML-850

K-Number: K827963 · 1982-09-13

Decision Date1982-09-13

Product Code

DecisionSubstantially Equivalent

Device Summary

MODEL ML-850 is the device name listed in this FDA 510(k) record. The listed applicant is Merrimack Laboratories. It received FDA 510(k) clearance on 1982-09-13 under 510(k) number K827963. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ML-850?

MODEL ML-850 is a medical device that received FDA 510(k) clearance on 1982-09-13. The listed applicant is Merrimack Laboratories. The 510(k) number is K827963.

When did MODEL ML-850 receive FDA 510(k) clearance?

MODEL ML-850 received FDA 510(k) clearance on 1982-09-13, under 510(k) number K827963.

Who is the listed applicant for MODEL ML-850?

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

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Other records listing Merrimack Laboratories as applicant

K833528CARBON DIOXIDE LASER ML 825 K833483ENDOSCOPIC COUPLER K827506MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY K827442ML-810 CARBON DIOXIDE LASER SYSTEM K800227ML-800 CO2

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.