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FDA 510(k), K030832, PRIMOSPLINT SYSTEM
FDA 510(k), K030832, PRIMOSPLINT SYSTEM
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510(K) Number: K030832
Device Name: PRIMOSPLINT SYSTEM
Manufacturer: MICHAEL O'MALLEY
Device Classification Name: Mouthguard, Prescription
Regulation Number: MQC
Classification Product Code: 03/17/2003
Date Received: 09/17/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: PRIMOSPLINT SYSTEM
Manufacturer: MICHAEL O'MALLEY
Device Classification Name: Mouthguard, Prescription
Regulation Number: MQC
Classification Product Code: 03/17/2003
Date Received: 09/17/2003
Decision Date: Substantially Equivalent (SESE)
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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