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 |