The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Lectrobrasive(r) E2401.
Device ID | K882646 |
510k Number | K882646 |
Device Name: | LECTROBRASIVE(R) E2401 |
Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-27 |
Decision Date | 1988-07-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884524001821 | K882646 | 000 |