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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K102683
Device Name THE ADDITION
Applicant
Ob The-Addition, LLC
2206 Modoc Rd. #3
Santa Barbara,  CA  93101
Applicant Contact Rebecca K Pine
Correspondent
Ob The-Addition, LLC
2206 Modoc Rd. #3
Santa Barbara,  CA  93101
Correspondent Contact Rebecca K Pine
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/17/2010
Decision Date 01/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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