The following data is part of a premarket notification filed by Laserscope with the FDA for Endostat.
Device ID | K914104 |
510k Number | K914104 |
Device Name: | ENDOSTAT |
Classification | Powered Laser Surgical Instrument |
Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Contact | Donna Page |
Correspondent | Donna Page LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-13 |
Decision Date | 1991-09-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOSTAT 76671820 not registered Dead/Abandoned |
THETA BIOMEDIAL CONSULTING AND DEVELOPMENT CO., INC. 2007-01-25 |
ENDOSTAT 74320277 not registered Dead/Abandoned |
VIR Engineering, Inc. 1992-10-05 |