The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Monopolar Lap Accessories.
| Device ID | K081503 |
| 510k Number | K081503 |
| Device Name: | AED MONOPOLAR LAP ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303 |
| Contact | Gayle M Butler |
| Correspondent | Gayle M Butler NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-09-25 |
| Summary: | summary |