The following data is part of a premarket notification filed by B.j.zh.f. Panther Medical Equipment Co., Ltd with the FDA for Panther Group Of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap.
| Device ID | K103470 |
| 510k Number | K103470 |
| Device Name: | PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP |
| Classification | Staple, Implantable |
| Applicant | B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD ROOM 1606 BLDG. 1 JIANXIANG YU NO. 209 BEI SI HUAN Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD ROOM 1606 BLDG. 1 JIANXIANG YU NO. 209 BEI SI HUAN Beijing, CN 100083 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-01-11 |
| Summary: | summary |