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 |