The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Compact Alpha Lithotripter.
| Device ID | K002929 |
| 510k Number | K002929 |
| Device Name: | DORNIER COMPACT ALPHA LITHOTRIPTER |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Carol Wernecke |
| Correspondent | Carol Wernecke DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-20 |
| Decision Date | 2001-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049957000028 | K002929 | 000 |
| 04049957000011 | K002929 | 000 |