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FDA 510(k), K141830, STIMULAN KIT, STIMULAN RAPID CURE
FDA 510(k), K141830, STIMULAN KIT, STIMULAN RAPID CURE
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510(K) Number: K141830
Device Name: STIMULAN KIT, STIMULAN RAPID CURE
Manufacturer: MARIE WHALLEY
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: KXA
Date Received: 07/07/2014
Decision Date: 01/23/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: STIMULAN KIT, STIMULAN RAPID CURE
Manufacturer: MARIE WHALLEY
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: KXA
Date Received: 07/07/2014
Decision Date: 01/23/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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