The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Breathable Impervious Gowns.
| Device ID | K012984 |
| 510k Number | K012984 |
| Device Name: | BREATHABLE IMPERVIOUS GOWNS |
| Classification | Gown, Surgical |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins 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 | 2001-09-06 |
| Decision Date | 2001-09-24 |
| Summary: | summary |