510(k) K850382
- Device
- IRIDIUM SEEDS
- Applicant
- RADIATION SAFETY & NUCLEAR PRODUCTS, INC.
- 510(k) number
- K850382
- Product code
- IWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-15
- Date received
- 1985-02-01
- Regulation
- 892.5730
- Classification name
- Source, Wire, Iridium, Radioactive
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDD JOHNSON
- Address
- 3641 W. 1987 S. Salt Lake City UT US 84104 84104
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K915253 | IR-192 IMPLANT, MODIFICATION | Omnitron Intl., Inc. | 1992-02-27 |
| K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | Amersham Corp. | 1989-09-29 |
| K874895 | IR-192 IMPLANT | Rads S.L., Inc. | 1988-02-25 |
| K844248 | IR-192 IMPLANT | Rads S.L., Inc. | 1985-04-10 |
| K850163 | IRIDIUM 192 WIRES | Syncor Intl. Corp. | 1985-03-26 |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Syncor Intl. Corp. | 1985-03-26 |
| K771878 | IRIDIUM 192 WIRES & PINS | Cis Radiopharmaceuticals, Inc. | 1977-10-27 |
Legacy Summary#
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FDA Review#
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