The following data is part of a premarket notification filed by Ab Medica S.a.s. with the FDA for Ab Medica Irrigation/suction Gravity System.
| Device ID | K151822 |
| 510k Number | K151822 |
| Device Name: | Ab Medica Irrigation/suction Gravity System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AB MEDICA S.A.S. LES PETITES QUARTEREES Mary-su-cher, FR 18100 |
| Contact | Alexandre Blanc |
| Correspondent | Alexandre Blanc AB MEDICA S.A.S. LES PETITES QUARTEREES Mary-su-cher, FR 18100 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E296OMSFLA051 | K151822 | 000 |
| E296OMSFLA041 | K151822 | 000 |
| E296OMSFLA031 | K151822 | 000 |
| E296OMSFLA02GESC1 | K151822 | 000 |
| E296OMSFLA02GE1 | K151822 | 000 |
| E496LILCD310 | K151822 | 000 |
| E496LILCD200 | K151822 | 000 |