510(k) K872369
- Device
- LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
- Applicant
- LOMA LINDA UNIVERSITY MEDICAL CENTER
- 510(k) number
- K872369
- Product code
- IWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-22
- Date received
- 1987-06-19
- Regulation
- 892.5050
- Classification name
- Synchrotron, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ANDERSON
- Address
- 11234 Anderson St. P.O. Box 2000 Loma Linda CA US 92354 92354
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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