1
/
of
0
FDA 510(k), K161138, St. Louis Band
FDA 510(k), K161138, St. Louis Band
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
Unit price
/
per
510(K) Number: K161138
Device Name: St. Louis Band
Manufacturer: DAVID C. KERR
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: KXA
Date Received: 04/22/2016
Decision Date: 07/20/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: St. Louis Band
Manufacturer: DAVID C. KERR
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: KXA
Date Received: 04/22/2016
Decision Date: 07/20/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Couldn't load pickup availability
- 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.
View full details