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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tip, Rubber, Oral Hygiene
510(k) Number K862635
Device Name RABINOWITZ GUM MASSAGER
Applicant
Arnell, Inc.
7016 N. 57th Ave.
Glendale,  AZ  85301
Applicant Contact LEWIS RABINOWITZ
Correspondent
Arnell, Inc.
7016 N. 57th Ave.
Glendale,  AZ  85301
Correspondent Contact LEWIS RABINOWITZ
Regulation Number872.6650
Classification Product Code
JEW  
Date Received07/10/1986
Decision Date 09/25/1986
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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