510(k) K964607
- Device
- THERATON 1000E
- Applicant
- THERATRONICS, INC.
- 510(k) number
- K964607
- Product code
- IWD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-28
- Date received
- 1996-11-18
- Regulation
- 892.5750
- Classification name
- Device, Beam Limiting, Teletherapy, Radionuclide
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- E.S. MARTELL
- Address
- 413 March Rd. P.O. Box 13140 Kanata, Ontario, Canada CA K2K 2B7 K2K 2B7
Source Documents#
Legacy Summary#
summary
FDA Review#
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