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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Endodontic Stabilizing
510(k) Number K922673
Device Name FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING
Applicant
Glasspan, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact EDWARD L KORWEK
Correspondent
Glasspan, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact EDWARD L KORWEK
Regulation Number872.3890
Classification Product Code
ELS  
Date Received06/04/1992
Decision Date 02/25/1994
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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