The following data is part of a premarket notification filed by Vectec with the FDA for Vectec Disposable Monopolar Connector Cable.
Device ID | K103707 |
510k Number | K103707 |
Device Name: | VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VECTEC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
Contact | Diane Mandell Horwitz |
Correspondent | Diane Mandell Horwitz VECTEC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-20 |
Decision Date | 2011-02-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03700393300318 | K103707 | 000 |