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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K895761
Device Name GENERAL ASPERATOR
Applicant
Kolster Methods
1895 W. Commonwealth Ave.
Unit 'G'
Fullerton,  CA  92633
Applicant Contact ALWIN KOLSTER
Correspondent
Kolster Methods
1895 W. Commonwealth Ave.
Unit 'G'
Fullerton,  CA  92633
Correspondent Contact ALWIN KOLSTER
Regulation Number878.4780
Classification Product Code
JCX  
Date Received09/26/1989
Decision Date 10/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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