The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Ligasure Vessel Sealing System.
Device ID | K981916 |
510k Number | K981916 |
Device Name: | LIGASURE VESSEL SEALING SYSTEM |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Contact | Charles Copperberg |
Correspondent | Charles Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-01 |
Decision Date | 1998-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884524001685 | K981916 | 000 |
10884521037199 | K981916 | 000 |
10884521175525 | K981916 | 000 |
10884524002712 | K981916 | 000 |
10884521546219 | K981916 | 000 |
20884524000647 | K981916 | 000 |
10884524001692 | K981916 | 000 |
10884524002132 | K981916 | 000 |
10884524002309 | K981916 | 000 |
10884524002705 | K981916 | 000 |
10884524002767 | K981916 | 000 |
10884524002965 | K981916 | 000 |
10884521175549 | K981916 | 000 |
20884524000289 | K981916 | 000 |
20884524002153 | K981916 | 000 |
20884524002511 | K981916 | 000 |
10884521038486 | K981916 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIGASURE VESSEL SEALING SYSTEM 76413160 2763674 Dead/Cancelled |
COVIDIEN AG 2002-05-29 |