Set, Oral Administration
FDA 510(k) K760251 · Cis Radiopharmaceuticals, Inc.
510(k) numberK760251
Submission
- Device name
- Set, Oral Administration
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- July 19, 1976
- Decision date
- September 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LEY – Set, Oral Administration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | 07/24/1979SE |
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| K771878 | Iridium 192 Wires & PinsIWA · Traditional | 10/27/1977SE |
Questions and answers
When was Set, Oral Administration cleared by the FDA?
Set, Oral Administration (K760251) received a 510(k) decision of Substantially Equivalent on September 15, 1976, 58 days after the submission was received.
What is the product code of K760251?
The FDA product code is LEY – Set, Oral Administration, a Class II (moderate risk) device regulated under 21 CFR 876.5980.