The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Laparoscopy Tray.
Device ID | K914036 |
510k Number | K914036 |
Device Name: | MEDSURG LAPAROSCOPY TRAY |
Classification | General Surgery Tray |
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 | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-10 |
Decision Date | 1992-03-18 |