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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
510(k) Number K072551
Device Name LD-I 75 AND LD-I 200
Applicant
MEDITECH INTERNATIONAL, INC.
1151 HOPE ST.
STAMFORD,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
MEDITECH INTERNATIONAL, INC.
1151 HOPE ST.
STAMFORD,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number890.5500
Classification Product Code
NHN  
Date Received09/10/2007
Decision Date 04/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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