The following data is part of a premarket notification filed by Lexington Medical Inc. with the FDA for Aeon Retrieval Bag.
| Device ID | K180114 |
| 510k Number | K180114 |
| Device Name: | AEON Retrieval Bag |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Lexington Medical Inc. 11 Executive Park Drive Billerica, MA 01862 |
| Contact | Donna Gasper |
| Correspondent | Donna Gasper Lexington Medical Inc. 11 Executive Park Drive Billerica, MA 01862 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851574008783 | K180114 | 000 |
| 00851574008745 | K180114 | 000 |