The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Percutaneous Introducer Tray.
| Device ID | K904608 |
| 510k Number | K904608 |
| Device Name: | PERCUTANEOUS INTRODUCER TRAY |
| Classification | Catheter, Percutaneous |
| Applicant | THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | G Catlin |
| Correspondent | G Catlin THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-12-03 |