The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E0520-trigger Switch And Cord/e0521-trigger Switch.
Device ID | K970140 |
510k Number | K970140 |
Device Name: | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | John Dicaro |
Correspondent | John Dicaro VALLEYLAB, INC. 5920 LONGBOW DR. 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 | 1997-01-15 |
Decision Date | 1997-03-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884524000425 | K970140 | 000 |