The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Bipolar Forceps, Model 13-1646.
| Device ID | K081553 |
| 510k Number | K081553 |
| Device Name: | AED BIPOLAR FORCEPS, MODEL 13-1646 |
| 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 | 2008-06-03 |
| Decision Date | 2008-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848657001458 | K081553 | 000 |
| 00848657074797 | K081553 | 000 |
| 00848657074803 | K081553 | 000 |
| 00848657084161 | K081553 | 000 |
| 00848657084178 | K081553 | 000 |
| 00848657085502 | K081553 | 000 |
| 00848657076630 | K081553 | 000 |
| 00848657083928 | K081553 | 000 |
| 00848657083942 | K081553 | 000 |
| 00848657084994 | K081553 | 000 |
| 00848657074780 | K081553 | 000 |