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FDA 510(k), K122361, T:CONNECT DATA MANAGEMENT SYSTEM
FDA 510(k), K122361, T:CONNECT DATA MANAGEMENT SYSTEM
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510(K) Number: K122361
Device Name: T:CONNECT DATA MANAGEMENT SYSTEM
Manufacturer: TANDEM DIABETES CARE, INC.
Device Classification Name: Medical Device Data System
Regulation Number: 880.6310
Classification Product Code: OUG
Date Received: 08/03/2012
Decision Date: 02/22/2013
Regulation Medical Specialty: General Hospital
Device Name: T:CONNECT DATA MANAGEMENT SYSTEM
Manufacturer: TANDEM DIABETES CARE, INC.
Device Classification Name: Medical Device Data System
Regulation Number: 880.6310
Classification Product Code: OUG
Date Received: 08/03/2012
Decision Date: 02/22/2013
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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