The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Angiographic, Wedge Press, Dual Thermod & Infusion.
| Device ID | K852914 |
| 510k Number | K852914 |
| Device Name: | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION |
| Classification | Catheter, Percutaneous |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Contact | Rogers Mogill |
| Correspondent | Rogers Mogill NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-10 |
| Decision Date | 1985-09-25 |