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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
510(k) Number K863375
Device Name SEA-BOND
Applicant
Combe, Inc.
1101 Westchester Ave.
White Plains,  NY  10604
Applicant Contact DANIEL R JOHNSON
Correspondent
Combe, Inc.
1101 Westchester Ave.
White Plains,  NY  10604
Correspondent Contact DANIEL R JOHNSON
Regulation Number872.3450
Classification Product Code
KXX  
Date Received09/03/1986
Decision Date 09/19/1986
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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