The following data is part of a premarket notification filed by Weihai Hongyu Nonwoven Fabric Products Co., Ltd with the FDA for Disposable Surgical Gowns.
| Device ID | K120192 |
| 510k Number | K120192 |
| Device Name: | DISPOSABLE SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD P.O. BOX 237-023 Weihai, KM 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD P.O. BOX 237-023 Weihai, KM 200030 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022960369 | K120192 | 000 |
| 00850022960352 | K120192 | 000 |
| 00850022960345 | K120192 | 000 |
| 00850022960338 | K120192 | 000 |
| 00850022960321 | K120192 | 000 |
| 06938024400121 | K120192 | 000 |
| 06938024400138 | K120192 | 000 |