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FDA 510(k), K113536, MASTERKA 40 MASTERKA 35 MASTERKA 30
FDA 510(k), K113536, MASTERKA 40 MASTERKA 35 MASTERKA 30
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510(K) Number: K113536
Device Name: MASTERKA 40 MASTERKA 35 MASTERKA 30
Manufacturer: FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
Device Classification Name: lacrimal stents and intubation sets
Regulation Number:
Classification Product Code: OKS
Date Received: 11/30/2011
Decision Date: 08/03/2012
Regulation Medical Specialty:
Device Name: MASTERKA 40 MASTERKA 35 MASTERKA 30
Manufacturer: FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
Device Classification Name: lacrimal stents and intubation sets
Regulation Number:
Classification Product Code: OKS
Date Received: 11/30/2011
Decision Date: 08/03/2012
Regulation Medical Specialty:
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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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