The following data is part of a premarket notification filed by Promedical Products Co., Ltd. with the FDA for Promedical Surgical Gown, Models 18-301, 18-401 And 18-501.
| Device ID | K091097 |
| 510k Number | K091097 |
| Device Name: | PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 |
| Classification | Gown, Surgical |
| Applicant | PROMEDICAL PRODUCTS CO., LTD. 5165 BROADWAY SUITE 116 Depew, NY 14043 -4012 |
| Contact | David Power |
| Correspondent | David Power PROMEDICAL PRODUCTS CO., LTD. 5165 BROADWAY SUITE 116 Depew, NY 14043 -4012 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-05-27 |