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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K854699
Device Name TUBING SYRING
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 Number872.4565
Classification Product Code
ECB  
Date Received11/21/1985
Decision Date 01/06/1986
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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