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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K813506
Device Name FARRORS TMJ CASSETTE HOLDER
Applicant
Brell Mar Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Brell Mar Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6025
Classification Product Code
KXF  
Date Received12/15/1981
Decision Date 01/29/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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