The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Series Sy Disposable Electrosurgical Pad.
| Device ID | K082204 |
| 510k Number | K082204 |
| Device Name: | SERIES SY DISPOSABLE ELECTROSURGICAL PAD |
| Classification | Electrosurgical Patient Return Electrode |
| Applicant | VENTLAB CORP. 1676 VILLAGE GREEN STE A Crofton, MD 21114 -4341 |
| Contact | Christina Norris |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ODR |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2008-08-13 |