The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Nu-thor Thoracostomy Kit.
Device ID | K842666 |
510k Number | K842666 |
Device Name: | NU-THOR THORACOSTOMY KIT |
Classification | Accessories, Catheter |
Applicant | INTL. MEDICAL DEVICES LTD. 530 SECO RD. Monroeville, PA 15146 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-10 |
Decision Date | 1984-09-20 |