The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Material Addition Lexan & K-resin.
| Device ID | K833554 |
| 510k Number | K833554 |
| Device Name: | MATERIAL ADDITION LEXAN & K-RESIN |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-05 |
| Decision Date | 1984-03-12 |