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FDA 510(k), K040161, SONA PILLOW
FDA 510(k), K040161, SONA PILLOW
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510(K) Number: K040161
Device Name: SONA PILLOW
Manufacturer: NAJEEB A ZUBERI
Device Classification Name: Pillow, Cervical (For Mild Sleep Apnea)
Regulation Number: MYB
Classification Product Code: KXA
Date Received: 01/23/2004
Decision Date: 04/30/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: SONA PILLOW
Manufacturer: NAJEEB A ZUBERI
Device Classification Name: Pillow, Cervical (For Mild Sleep Apnea)
Regulation Number: MYB
Classification Product Code: KXA
Date Received: 01/23/2004
Decision Date: 04/30/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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