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FDA 510(k), K041718, KELES FACEMASK
FDA 510(k), K041718, KELES FACEMASK
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$149.00 USD
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510(K) Number: K041718
Device Name: KELES FACEMASK
Manufacturer: GREAT LAKES ORTHODONTICS, LTD.
Device Classification Name: headgear, extraoral, orthodontic
Regulation Number: 872.5500
Classification Product Code: DZB
Date Received: 06/24/2004
Decision Date: 10/15/2004
Regulation Medical Specialty: Dental
Device Name: KELES FACEMASK
Manufacturer: GREAT LAKES ORTHODONTICS, LTD.
Device Classification Name: headgear, extraoral, orthodontic
Regulation Number: 872.5500
Classification Product Code: DZB
Date Received: 06/24/2004
Decision Date: 10/15/2004
Regulation Medical Specialty: Dental
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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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