The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Set, Oral Administration.
Device ID | K760251 |
510k Number | K760251 |
Device Name: | SET, ORAL ADMINISTRATION |
Classification | Set, Oral Administration |
Applicant | CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LEY |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-19 |
Decision Date | 1976-09-15 |