The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Sterile O.r. Towels.
Device ID | K940175 |
510k Number | K940175 |
Device Name: | MEDSURG STERILE O.R. TOWELS |
Classification | Drape, Surgical |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Thomas B Bonner, Jr. |
Correspondent | Thomas B Bonner, Jr. MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-11 |
Decision Date | 1994-05-26 |