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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K895762
Device Name CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
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 Number878.4800
Classification Product Code
GEA  
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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