The following data is part of a premarket notification filed by Bioenterics Corp. with the FDA for Gastric Suction And Drainage Catheter.
| Device ID | K002838 |
| 510k Number | K002838 |
| Device Name: | GASTRIC SUCTION AND DRAINAGE CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BIOENTERICS CORP. 1035 CINDY LN. Carpinteria, CA 93013 |
| Contact | David Munjal |
| Correspondent | David Munjal BIOENTERICS CORP. 1035 CINDY LN. Carpinteria, CA 93013 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-12 |
| Decision Date | 2001-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007764203 | K002838 | 000 |