The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Insertion Tray.
Device ID | K920780 |
510k Number | K920780 |
Device Name: | MEDSURG INSERTION TRAY |
Classification | Catheter, Subclavian |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Thomas Bonner |
Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-20 |
Decision Date | 1994-08-19 |