The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Imc Surgical Drape.
Device ID | K100991 |
510k Number | K100991 |
Device Name: | IMC SURGICAL DRAPE |
Classification | Drape, Surgical |
Applicant | INTERNATIONAL MEDSURG CONNECTION 935 N. PLUM GROVE ROAD, SUITE F Schaumburg, IL 60173 |
Contact | Peter Kim |
Correspondent | Peter Kim INTERNATIONAL MEDSURG CONNECTION 935 N. PLUM GROVE ROAD, SUITE F Schaumburg, IL 60173 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-09 |
Decision Date | 2010-10-05 |
Summary: | summary |