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FDA 510(k), K212045, SoftSpot
FDA 510(k), K212045, SoftSpot
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$149.00 USD
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510(K) Number: K212045
Device Name: SoftSpot
Manufacturer: PediaMetrix, Inc.
Device Classification Name: Cranial Measurement Software
Regulation Number: 878.4800
Classification Product Code: QQO
Date Received: 06/30/2021
Decision Date: 09/28/2021
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SoftSpot
Manufacturer: PediaMetrix, Inc.
Device Classification Name: Cranial Measurement Software
Regulation Number: 878.4800
Classification Product Code: QQO
Date Received: 06/30/2021
Decision Date: 09/28/2021
Regulation Medical Specialty: General & Plastic Surgery
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- 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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