Pre-market Notification Details
DeNovo ID | DEN210013 |
Device Name: | OsteoProbe |
Classification | Bone Indentation Device |
Applicant | Active Life Scientific, Inc. 1027 Garden Street Santa Barbara, CA 93101 |
Contact | Alexander Proctor |
Product Code | QGQ |
CFR Regulation Number | 888.1600 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Orthopedic |
Classification Advisory | Orthopedic |
Type | Direct |
Date Received | 2021-03-30 |
Decision Date | 2021-08-19 |
Reclassification Order: | Reclassification Order |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
10860001719397 |
DEN210013 |
000 |
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