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Directory Results for 510(K) SUMMARY This summary of safety and effectiveness ination is being submitted in accordance with the requirements of SMDA 1990 and 21CER 807 - accessdata fda to 510(K) Summary, 510(k) K122550 Submitter: ON Otometrics A/S Hoerskaetten 9 Tanstrup, FEB DENMARK DK2630 Registration number: 9612197 C/O ON Otometrics North America 50 Commerce Dr Ste 180 Schaumburg, IL 60173 (US) Phone: 8475342150 (US) - -

510(K) SUMMARY This summary of safety and effectiveness ination is being submitted in accordance with the requirements of SMDA 1990 and 21CER 807 - accessdata fda
510(k) Summary Trade Name : Sponsor: Spirus Medical, Inc. 1063 ... - accessdata fda
510(k) SUMMARY Traditional Premarket Notification 510(k) FusionSync 510(k) SUMMARY DEC 16 2013 0 CHIMAERA 5 10O(k) summary of safety and effectiveness (21 CUR 807 - accessdata fda
510(K) Summary, 510(k) K122550 Submitter: ON Otometrics A/S Hoerskaetten 9 Tanstrup, FEB DENMARK DK2630 Registration number: 9612197 C/O ON Otometrics North America 50 Commerce Dr Ste 180 Schaumburg, IL 60173 (US) Phone: 8475342150 (US) - -