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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scraper, Tongue
510(k) Number K942076
Device Name TONGUE SCRAPER
Applicant
Maharishi Ayur-Ved
417 Bolton Rd.
P.O. Box 541
Lancaster,  MA  01523
Applicant Contact STEVE BARTHE
Correspondent
Maharishi Ayur-Ved
417 Bolton Rd.
P.O. Box 541
Lancaster,  MA  01523
Correspondent Contact STEVE BARTHE
Regulation Number872.6855
Classification Product Code
LCN  
Date Received04/29/1994
Decision Date 08/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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