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FDA 510(k), K131113, BIOPHOTAS CELLUMA
FDA 510(k), K131113, BIOPHOTAS CELLUMA
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510(K) Number: K131113
Device Name: BIOPHOTAS CELLUMA
Manufacturer: BIOPHOTAS, INC.
Device Classification Name: lamp, infrared, therapeutic heating
Regulation Number: 890.5500
Classification Product Code: ILY
Date Received: 04/22/2013
Decision Date: 01/15/2014
Regulation Medical Specialty: Physical Medicine
Device Name: BIOPHOTAS CELLUMA
Manufacturer: BIOPHOTAS, INC.
Device Classification Name: lamp, infrared, therapeutic heating
Regulation Number: 890.5500
Classification Product Code: ILY
Date Received: 04/22/2013
Decision Date: 01/15/2014
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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