510(k) K760251
- Device
- SET, ORAL ADMINISTRATION
- Applicant
- CIS RADIOPHARMACEUTICALS, INC.
- 510(k) number
- K760251
- Product code
- LEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-09-15
- Date received
- 1976-07-19
- Regulation
- 876.5980
- Classification name
- Set, Oral Administration
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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