The following data is part of a premarket notification filed by Advanced Medical Design Co., Ltd. with the FDA for Lab Bag With Fabric Pouch.
| Device ID | K210248 |
| 510k Number | K210248 |
| Device Name: | Lab Bag With Fabric Pouch |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Advanced Medical Design Co., Ltd. 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, TW 248018 |
| Contact | Silvia Yeh |
| Correspondent | Jose Wang Advanced Medical Design Co., Ltd. 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, TW 248018 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-07-30 |