The following data is part of a premarket notification filed by Osmunda Medical Device Consulting Co., Ltd. with the FDA for Extracorporeal Shock Wave Lithotripter.
| Device ID | K131817 |
| 510k Number | K131817 |
| Device Name: | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. NO. 982 COGYUN ROAD BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. NO. 982 COGYUN ROAD BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975438931018 | K131817 | 000 |