510(k) K091992
- Device
- EIDOSMED, MODEL EDG4.0
- Applicant
- EIDOSMED, LLC
- 510(k) number
- K091992
- Product code
- OOL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-09
- Date received
- 2009-07-02
- Regulation
- 888.3030
- Classification name
- Electronic Depth Gauge
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL KAMM
- Address
- 333 Milford Rd. Deerfield IL US 60015 60015
FDA Registration Numbers#
- 3007829657
- 3014282569
- 1047843
Source Documents#
Legacy Summary#
summary
FDA Review#
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