The following data is part of a premarket notification filed by Clairson Industries, Llc. with the FDA for Easi-lav Adult Gastric Lavage Kit.
Device ID | K896573 |
510k Number | K896573 |
Device Name: | EASI-LAV ADULT GASTRIC LAVAGE KIT |
Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
Applicant | CLAIRSON INDUSTRIES, LLC. 2811 N.E. 14TH ST. Ocala, FL 34470 |
Contact | Philip K Effinger |
Correspondent | Philip K Effinger CLAIRSON INDUSTRIES, LLC. 2811 N.E. 14TH ST. Ocala, FL 34470 |
Product Code | KDH |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-20 |
Decision Date | 1990-01-29 |