The following data is part of a premarket notification filed by Changzhou Waston Medical Appliance Co. Ltd with the FDA for Disposable Circular Stapler, Models Why-25, Why-29. Why 32.
| Device ID | K100386 |
| 510k Number | K100386 |
| Device Name: | DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-01 |
| Summary: | summary |