510(k) K871116
- Device
- X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
- Applicant
- X-CEL X-RAY CORP.
- 510(k) number
- K871116
- Product code
- IYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-14
- Date received
- 1987-03-19
- Regulation
- 892.5900
- Classification name
- Generator, Dermatological (grenz Ray), Therapeutic X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM W MORRIS
- Address
- 4220 Waller Dr., P.O. Box 1857 Crystal Lake IL US 60039 60039
FDA Registration Numbers#
- 1418484
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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