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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Suction, Uterine
510(k) Number K935820
Device Name KOLSTER METHODS
Applicant
Kolster Methods
2550 W. Rowland Ave.
Anaheim,  CA  92804
Applicant Contact ALVIN KOLSTER
Correspondent
Kolster Methods
2550 W. Rowland Ave.
Anaheim,  CA  92804
Correspondent Contact ALVIN KOLSTER
Regulation Number884.5070
Classification Product Code
HGH  
Date Received12/03/1993
Decision Date 07/19/1994
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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