The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Epidural Tray/19 Gage Open End Tuohy 1012.
Device ID | K890733 |
510k Number | K890733 |
Device Name: | MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012 |
Classification | Anesthesia Conduction Kit |
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 | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-06-23 |