The following data is part of a premarket notification filed by Intl. Medsurg Connection, Inc. with the FDA for Imc Surgical Gowns.
| Device ID | K052550 |
| 510k Number | K052550 |
| Device Name: | IMC SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | INTL. MEDSURG CONNECTION, INC. 935 N. PLUM GROVE RD. STE. F Schaumburg, IL 60173 -4770 |
| Contact | Manny Gupta |
| Correspondent | Manny Gupta INTL. MEDSURG CONNECTION, INC. 935 N. PLUM GROVE RD. STE. F Schaumburg, IL 60173 -4770 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2005-11-17 |
| Summary: | summary |