The following data is part of a premarket notification filed by Suzhou Frankenman Medical Equipment Co., Ltd. with the FDA for Frankenman Surgical Staplers.
| Device ID | K101378 |
| 510k Number | K101378 |
| Device Name: | FRANKENMAN SURGICAL STAPLERS |
| Classification | Staple, Implantable |
| Applicant | SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2010-06-29 |
| Summary: | summary |