510(k) K924759
- Device
- COLLIMATOR LIGHT SOURCE
- Applicant
- DENAR CORP.
- 510(k) number
- K924759
- Product code
- IZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-09
- Date received
- 1992-09-23
- Regulation
- 892.1610
- Classification name
- Cone, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS J MULDOON
- Address
- 333 W. Wacker Dr. Suite 2600 Chicago IL US 60606 60606
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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