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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 K844292
Device Name MEDI-TECH DILATATION CATHETERS
Applicant
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact SAMUEL D WADE
Correspondent
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact SAMUEL D WADE
Regulation Number872.6855
Classification Product Code
LCN  
Date Received11/05/1984
Decision Date 11/23/1984
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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