The following data is part of a premarket notification filed by International Medsurg Connection, Inc. with the FDA for Imc Surgical Drapes.
Device ID | K052169 |
510k Number | K052169 |
Device Name: | IMC SURGICAL DRAPES |
Classification | Drape, Surgical |
Applicant | INTERNATIONAL MEDSURG CONNECTION, INC. 935 NORTH PLUM GROVE RD. SUITE F Schaumburg, IL 60173 |
Contact | Manny Gupta |
Correspondent | Manny Gupta INTERNATIONAL MEDSURG CONNECTION, INC. 935 NORTH PLUM GROVE RD. 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 | 2005-08-09 |
Decision Date | 2005-11-17 |
Summary: | summary |