The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Resectoscope.
| Device ID | K102663 |
| 510k Number | K102663 |
| Device Name: | AED RESECTOSCOPE |
| Classification | Resectoscope |
| Applicant | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303 |
| Contact | Gayle Butler |
| Correspondent | Gayle Butler NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303 |
| Product Code | FJL |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FDC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-12-30 |
| Summary: | summary |