FDA 510(k), K080042, SPIRUS MEDICAL SURGICAL INSTRUMENT
FDA 510(k), K080042, SPIRUS MEDICAL SURGICAL INSTRUMENT
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510(K) Number: K080042
Device Name: SPIRUS MEDICAL SURGICAL INSTRUMENT
Manufacturer: PAMELA PAPINEAU
Device Classification Name: Lubricant, Patient
Regulation Number: KMJ
Classification Product Code: 01/08/2008
Date Received: 04/03/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SPIRUS MEDICAL SURGICAL INSTRUMENT
Manufacturer: PAMELA PAPINEAU
Device Classification Name: Lubricant, Patient
Regulation Number: KMJ
Classification Product Code: 01/08/2008
Date Received: 04/03/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
- 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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