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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K833528
Device Name CARBON DIOXIDE LASER ML 825
Applicant
Merrimack Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Merrimack Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.4550
Classification Product Code
HHR  
Date Received09/23/1983
Decision Date 02/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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