The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E600b Footswitch.
Device ID | K874794 |
510k Number | K874794 |
Device Name: | E600B FOOTSWITCH |
Classification | Unit, Electrosurgical And Coagulation, With Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Peggy Walline |
Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Product Code | BWA |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-23 |
Decision Date | 1987-12-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521766662 | K874794 | 000 |
10884524001647 | K874794 | 000 |