The following data is part of a premarket notification filed by Medtek Devices, Inc. with the FDA for Lapevac, Filtration Device For The Periotoneum.
| Device ID | K052797 |
| 510k Number | K052797 |
| Device Name: | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | MEDTEK DEVICES, INC. 595 COMMERCE DR. Amherst, NY 14228 |
| Contact | Robert O Dean |
| Correspondent | Robert O Dean MEDTEK DEVICES, INC. 595 COMMERCE DR. Amherst, NY 14228 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-02-13 |
| Summary: | summary |