The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Lithoskop.
Device ID | K070665 |
510k Number | K070665 |
Device Name: | LITHOSKOP |
Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern, PA 19355 |
Contact | Kim Rendon |
Correspondent | Kim Rendon SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern, PA 19355 |
Product Code | LNS |
CFR Regulation Number | 876.5990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-12 |
Decision Date | 2008-01-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LITHOSKOP 79010168 3127097 Dead/Cancelled |
Siemens Aktiengesellschaft 2005-02-17 |