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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 K902164
Device Name SYB, OR SAVE YOUR BREATH TONGUE CLEANER
Applicant
P.J., Inc.
4704 Revere Dr.
Virginia Beach,  VA  23456
Applicant Contact PRASAD JONNAL
Correspondent
P.J., Inc.
4704 Revere Dr.
Virginia Beach,  VA  23456
Correspondent Contact PRASAD JONNAL
Regulation Number872.6855
Classification Product Code
LCN  
Date Received05/15/1990
Decision Date 10/12/1990
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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