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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 K844431
Device Name YN CO2 LASER SYSTEM 30W
Applicant
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Applicant Contact RICHARD E FRANKO
Correspondent
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Correspondent Contact RICHARD E FRANKO
Regulation Number884.4550
Classification Product Code
HHR  
Date Received11/16/1984
Decision Date 02/25/1985
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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