The following data is part of a premarket notification filed by Comed Medical Systems Co., Ltd with the FDA for Extracorporeal Shock Wave Lithotripter, Comed Asadal-m1.
| Device ID | K131721 |
| 510k Number | K131721 |
| Device Name: | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | COMED MEDICAL SYSTEMS CO., LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss COMED MEDICAL SYSTEMS CO., LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-12 |
| Decision Date | 2014-07-22 |
| Summary: | summary |