The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E7512 Premie Rem Polyhesive Ii Patient Return Electrode.
| Device ID | K994428 |
| 510k Number | K994428 |
| Device Name: | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Robert C Moore Jr |
| Correspondent | Robert C Moore Jr 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-30 |
| Decision Date | 2000-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001064 | K994428 | 000 |