510(k) K841359
- Device
- FENESTRA HOOK
- Applicant
- TREACE MEDICAL, INC.
- 510(k) number
- K841359
- Product code
- IYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-18
- Date received
- 1984-04-02
- Regulation
- 892.5900
- Classification name
- Collimator, Dermatological, Therapeutic X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9614698
- 2134213
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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