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FDA 510(k), K124026, LOBSTER AUTO-INJECTOR
FDA 510(k), K124026, LOBSTER AUTO-INJECTOR
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510(K) Number: K124026
Device Name: LOBSTER AUTO-INJECTOR
Manufacturer: SCANDINAVIAN HEALTH LIMITED
Device Classification Name: introducer, syringe needle
Regulation Number: 880.6920
Classification Product Code: KZH
Date Received: 12/28/2012
Decision Date: 09/13/2013
Regulation Medical Specialty: General Hospital
Device Name: LOBSTER AUTO-INJECTOR
Manufacturer: SCANDINAVIAN HEALTH LIMITED
Device Classification Name: introducer, syringe needle
Regulation Number: 880.6920
Classification Product Code: KZH
Date Received: 12/28/2012
Decision Date: 09/13/2013
Regulation Medical Specialty: General Hospital
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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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