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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 K772023
Device Name OB/GYN LASER, MODEL 920
Applicant
PHOTON SOURCES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHOTON SOURCES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4550
Classification Product Code
HHR  
Date Received10/21/1977
Decision Date 11/18/1977
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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