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510(k) Documents – spaceOAR (DEN140030) Submission Records & Regulatory Materials
510(k) Documents – spaceOAR (DEN140030) Submission Records & Regulatory Materials
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510(K) Number:
Device Name:
Manufacturer:
Device Classification Name:
Regulation Number:
Classification Product Code:
Date Received: 01/00/1900
Decision Date: 01/00/1900
Regulation Medical Specialty:
Request Contents: spaceOAR (DEN140030) documents, including all submission records, regulatory decision summaries, and de novo classification materials.
Device Name:
Manufacturer:
Device Classification Name:
Regulation Number:
Classification Product Code:
Date Received: 01/00/1900
Decision Date: 01/00/1900
Regulation Medical Specialty:
Request Contents: spaceOAR (DEN140030) documents, including all submission records, regulatory decision summaries, and de novo classification materials.
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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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