The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Tripter X-1 Compact Duet.
Device ID | K023535 |
510k Number | K023535 |
Device Name: | TRIPTER X-1 COMPACT DUET |
Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
Applicant | DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760 |
Contact | Larisa Gershtein |
Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760 |
Product Code | LNS |
CFR Regulation Number | 876.5990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-21 |
Decision Date | 2003-01-17 |
Summary: | summary |