The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Disimetric Release Of Instranetics Rad.
| Device ID | K830786 |
| 510k Number | K830786 |
| Device Name: | DISIMETRIC RELEASE OF INSTRANETICS RAD |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-11 |
| Decision Date | 1983-05-18 |