The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Myelogram Tray.
Device ID | K880693 |
510k Number | K880693 |
Device Name: | MEDSURG MYELOGRAM TRAY |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-22 |
Decision Date | 1988-05-11 |