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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K895563
Device Name PEMACO BITE WAX SHEETS
Applicant
Pemaco, Inc.
1345 W. Lark Industrial
Park
Fenton,  MO  63026
Applicant Contact RICHARD PERKOWSKI
Correspondent
Pemaco, Inc.
1345 W. Lark Industrial
Park
Fenton,  MO  63026
Correspondent Contact RICHARD PERKOWSKI
Regulation Number872.6890
Classification Product Code
EGD  
Date Received09/06/1989
Decision Date 11/06/1989
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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