The following data is part of a premarket notification filed by Sidam S.r.l with the FDA for Cyber Blade.
Device ID | K192499 |
510k Number | K192499 |
Device Name: | Cyber Blade |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Sidam S.r.l Via Statale Sud, 169 Mirandola (bo), IT 41037 |
Contact | Andrea Tromba |
Correspondent | Andrea Tromba Sidam S.r.l Via Statale Sud, 169 Mirandola (mo), IT 41037 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-11 |
Decision Date | 2020-07-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08059173391707 | K192499 | 000 |
08059173391691 | K192499 | 000 |
08051414960482 | K192499 | 000 |
08051414960475 | K192499 | 000 |
18051414960465 | K192499 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CYBER BLADE 88733069 not registered Live/Pending |
QUANTA SYSTEM S.P.A. 2019-12-19 |
CYBER BLADE 76113302 not registered Dead/Abandoned |
SOURCE TECHNOLOGY INTERNATIONAL 2000-08-18 |