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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 K862444
Device Name FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
Applicant
LASER MEDIA
77 ARKAY DR.
HAUPPAUGE,  NY  11788
Applicant Contact ROBERT A KAPLAN
Correspondent
LASER MEDIA
77 ARKAY DR.
HAUPPAUGE,  NY  11788
Correspondent Contact ROBERT A KAPLAN
Regulation Number884.4550
Classification Product Code
HHR  
Date Received06/26/1986
Decision Date 09/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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