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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 K951162
Device Name PHENO-CEN GERMICIDAL DETERGENT
Applicant
Central Solutions, Inc.
3130 Brinkerhoff Rd.
Kansas City,  KS  66115
Applicant Contact GARY W HELTON
Correspondent
Central Solutions, Inc.
3130 Brinkerhoff Rd.
Kansas City,  KS  66115
Correspondent Contact GARY W HELTON
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received03/14/1995
Decision Date 07/11/1995
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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