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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K100847
Device Name SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
Applicant
Biocompatibles, Inc.
115 Hurley Rd.
Oxford,  CT  06708
Applicant Contact WAYNE W RICHARDSON
Correspondent
Biocompatibles, Inc.
115 Hurley Rd.
Oxford,  CT  06708
Correspondent Contact WAYNE W RICHARDSON
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/25/2010
Decision Date 05/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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