The following data is part of a premarket notification filed by Jiangsu Guangda Medical Material, Co., Ltd with the FDA for Surgical Gown, Sms.
| Device ID | K121152 |
| 510k Number | K121152 |
| Device Name: | SURGICAL GOWN, SMS |
| Classification | Gown, Surgical |
| Applicant | JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD 7305 HANCOCK VILLAGE DR SUITE 109 Chesterfield, VA 23832 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD 7305 HANCOCK VILLAGE DR SUITE 109 Chesterfield, VA 23832 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03615140002219 | K121152 | 000 |
| 03615140002127 | K121152 | 000 |
| 03615140005067 | K121152 | 000 |