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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 K844829
Device Name ABDOMINAL PRESSURE CONTROL VALVE
Applicant
L.A.S.E.R., Inc.
100 S. Wacker Dr.
Chicago,  IL  60606
Applicant Contact ROBERT E BROWNE
Correspondent
L.A.S.E.R., Inc.
100 S. Wacker Dr.
Chicago,  IL  60606
Correspondent Contact ROBERT E BROWNE
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/12/1984
Decision Date 05/01/1985
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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