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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K854701
Device Name RETRACT-A-CORD
Applicant
Almore Intl., Inc.
Post Office Box 25214
Portland,  OR  97225
Applicant Contact MORIN
Correspondent
Almore Intl., Inc.
Post Office Box 25214
Portland,  OR  97225
Correspondent Contact MORIN
Regulation Number872.6390
Classification Product Code
JES  
Date Received11/21/1985
Decision Date 03/06/1986
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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