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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 K971025
Device Name AYURVEDIC TONGUE CLEANER
Applicant
Calello Martinez P.C.
675 Franklin Ave.
Nutley,  NJ  07110
Applicant Contact ANTONIO C MARTINEZ, II
Correspondent
Calello Martinez P.C.
675 Franklin Ave.
Nutley,  NJ  07110
Correspondent Contact ANTONIO C MARTINEZ, II
Regulation Number872.6855
Classification Product Code
LCN  
Date Received03/20/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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