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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 K851425
Device Name MODEL J25-25 WATT CO2 LASER
Applicant
Britt Corp., Inc.
2231 S. Barrington Ave.
Los Angeles,  CA  90064
Applicant Contact JOHN J MCDONALD
Correspondent
Britt Corp., Inc.
2231 S. Barrington Ave.
Los Angeles,  CA  90064
Correspondent Contact JOHN J MCDONALD
Regulation Number884.4550
Classification Product Code
HHR  
Date Received04/10/1985
Decision Date 11/12/1985
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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