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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K895756
Device Name MIKRO-AQUAPURATOR
Applicant
Mikro-Tek Laboratories
220 S. Lori Ln.
Bloomington,  IN  47401
Applicant Contact THOMAS P CLEMENT
Correspondent
Mikro-Tek Laboratories
220 S. Lori Ln.
Bloomington,  IN  47401
Correspondent Contact THOMAS P CLEMENT
Regulation Number878.4200
Classification Product Code
GBX  
Date Received09/26/1989
Decision Date 12/27/1989
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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