The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Vygon Thoracic Drainage-various #'s.
Device ID | K832628 |
510k Number | K832628 |
Device Name: | VYGON THORACIC DRAINAGE-VARIOUS #'S |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | EXCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-04 |
Decision Date | 1984-01-30 |