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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Disinfectant, Medical Devices
510(k) Number K955850
Device Name PRO-TECH
Applicant
Central Solutions, Inc.
3130 Brinkerhoff Rd.
P.O. Box 15276
Kansas City,  KS  66115
Applicant Contact PAUL J NOBREGA
Correspondent
Central Solutions, Inc.
3130 Brinkerhoff Rd.
P.O. Box 15276
Kansas City,  KS  66115
Correspondent Contact PAUL J NOBREGA
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received12/27/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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