The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Laparoscope.
| Device ID | K993688 |
| 510k Number | K993688 |
| Device Name: | AED LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles, CA 90064 |
| Contact | Gayle M Butler |
| Correspondent | Gayle M Butler NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles, CA 90064 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 1999-12-06 |