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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848657069458 | K993688 | 000 |
| 00848657087179 | K993688 | 000 |
| 00848657087186 | K993688 | 000 |
| 00848657087193 | K993688 | 000 |
| 00848657087209 | K993688 | 000 |
| 00848657087506 | K993688 | 000 |
| 00848657087513 | K993688 | 000 |
| 00848657067218 | K993688 | 000 |
| 00848657084031 | K993688 | 000 |
| 00848657087162 | K993688 | 000 |
| 00848657087155 | K993688 | 000 |
| 00848657074896 | K993688 | 000 |
| 00848657075787 | K993688 | 000 |
| 00848657075794 | K993688 | 000 |
| 00848657015530 | K993688 | 000 |
| 00848657072335 | K993688 | 000 |
| 00848657084000 | K993688 | 000 |
| 00848657087117 | K993688 | 000 |
| 00848657087148 | K993688 | 000 |
| 00848657084048 | K993688 | 000 |
| 00848657084277 | K993688 | 000 |
| 00848657084987 | K993688 | 000 |
| 00848657014915 | K993688 | 000 |
| 00848657016568 | K993688 | 000 |
| 00848657023573 | K993688 | 000 |
| 00848657023580 | K993688 | 000 |
| 00848657023597 | K993688 | 000 |
| 00848657023603 | K993688 | 000 |
| 00848657085298 | K993688 | 000 |
| 00848657085304 | K993688 | 000 |
| 00848657014892 | K993688 | 000 |
| 00848657014816 | K993688 | 000 |
| 00848657000796 | K993688 | 000 |
| 00848657002813 | K993688 | 000 |
| 00848657002820 | K993688 | 000 |
| 00848657002844 | K993688 | 000 |
| 00848657012942 | K993688 | 000 |
| 00848657012959 | K993688 | 000 |
| 00848657013758 | K993688 | 000 |
| 00848657014793 | K993688 | 000 |
| 00848657085755 | K993688 | 000 |