510(k) K915253
- Device
- IR-192 IMPLANT, MODIFICATION
- Applicant
- OMNITRON INTL., INC.
- 510(k) number
- K915253
- Product code
- IWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-27
- Date received
- 1991-11-18
- Regulation
- 892.5730
- Classification name
- Source, Wire, Iridium, Radioactive
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM F LIPRIE
- Address
- P.O. Box 5247 3409 W. Prie Lake Rd. Lajke Charles LA US 70606 70606
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | Amersham Corp. | 1989-09-29 |
| K874895 | IR-192 IMPLANT | Rads S.L., Inc. | 1988-02-25 |
| K850382 | IRIDIUM SEEDS | Radiation Safety & Nuclear Products, Inc. | 1985-08-15 |
| 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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