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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 K854470
Device Name PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
Applicant
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number884.4550
Classification Product Code
HHR  
Date Received11/06/1985
Decision Date 02/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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