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 Cutter Stapler.
| Device ID | K152618 |
| 510k Number | K152618 |
| Device Name: | PANTHER Cutter Stapler |
| Classification | Staple, Implantable |
| Applicant | B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD ROOM 3305A, FLOOR 3, BLDG 3, NO.208 BLOCK 2 LIZA PARK, WANGJING INDUSTRIAL DIST. Beijing, CN 100102 |
| Contact | Lina Yun |
| Correspondent | Diana Hong MID-LINK CONSULTING CO.,LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2015-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939282478037 | K152618 | 000 |