The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Breathable Surgical Gown.
| Device ID | K023167 |
| 510k Number | K023167 |
| Device Name: | BREATHABLE SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-23 |
| Decision Date | 2002-10-02 |
| Summary: | summary |