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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 K952302
Device Name AMUCHINA
Applicant
Amuchina Intl., Inc.
200 Orchard Ridge Dr.
Suite 220
Gaithersburg,  MD  20878
Correspondent
Amuchina Intl., Inc.
200 Orchard Ridge Dr.
Suite 220
Gaithersburg,  MD  20878
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received05/16/1995
Decision Date 07/26/1995
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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