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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 K863520
Device Name CO2 LASER MICROMANIPULATOR
Applicant
Laser Spectrum, Inc.
5005 Newport Dr. Suite 404
Rolling Meadows,  IL  60008
Applicant Contact JOHN GAGLIARDO
Correspondent
Laser Spectrum, Inc.
5005 Newport Dr. Suite 404
Rolling Meadows,  IL  60008
Correspondent Contact JOHN GAGLIARDO
Regulation Number884.4550
Classification Product Code
HHR  
Date Received09/10/1986
Decision Date 10/06/1986
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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