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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Dental)
510(k) Number K760570
Device Name ROBINSON MIDDLE EAR PROSTHESIS
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number872.4565
Classification Product Code
EIB  
Date Received09/01/1976
Decision Date 09/21/1976
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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