The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Easi-lav Pediatric / Adult Gastric Lavage Kit.
| Device ID | K951533 |
| 510k Number | K951533 |
| Device Name: | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | E. M Chamberlain |
| Correspondent | E. M Chamberlain BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770927968 | K951533 | 000 |
| 30680651927966 | K951533 | 000 |
| 10350770927807 | K951533 | 000 |
| 10350770927753 | K951533 | 000 |
| 10350770927746 | K951533 | 000 |