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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K944885
Device Name DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000
Applicant
Kolvin Industries , Ltd.
Unit 6,M/F.,Century Centre,
44 Hung To Rd.,Kwun Tong
Kowloon,  HK
Applicant Contact S N LIE
Correspondent
Kolvin Industries , Ltd.
Unit 6,M/F.,Century Centre,
44 Hung To Rd.,Kwun Tong
Kowloon,  HK
Correspondent Contact S N LIE
Regulation Number890.5660
Classification Product Code
ISA  
Date Received10/03/1994
Decision Date 02/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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