K827442Substantially Equivalent

Ml-810 Carbon Dioxide Laser System

Name: K827442 Ml-810 Carbon Dioxide Laser System
Creator: Merrimack Laboratories
Published: 1982-05-19
License: https://open.fda.gov/license/

Merrimack Laboratories, Hudson MA / Traditional, Substantially Equivalent

FDA source

K827442 is the FDA 510(k) clearance record for ML-810 CARBON DIOXIDE LASER SYSTEM, cleared for Merrimack Laboratories on 1982-05-19. FDA records list 6 510(k) clearances for Merrimack Laboratories, from 1980-03-03 to 1985-02-19. As of 2026-09-10, FDA records show no recalls naming K827442.

Clearance record

Decision date: 1982-05-19
Received: 1982-04-16 (33 days to decision)
Review panel: Unknown
Applicant: Merrimack Laboratories 34 Tower St., Hudson MA
Third party review: No