The following data is part of a premarket notification filed by Elite Medical Inc with the FDA for Em-9000.
| Device ID | K101482 |
| 510k Number | K101482 |
| Device Name: | EM-9000 |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | ELITE MEDICAL INC 4343 SHALLOWFORD ROAD SUITE H-4B MARIETTA Atlanta, GA 30062 |
| Contact | Steven J De Brock |
| Correspondent | Steven J De Brock ELITE MEDICAL INC 4343 SHALLOWFORD ROAD SUITE H-4B MARIETTA Atlanta, GA 30062 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2011-03-31 |
| Summary: | summary |