The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Entri Flex Feeding Tube.
| Device ID | K833621 |
| 510k Number | K833621 |
| Device Name: | ENTRI FLEX FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. Somerville, NJ 08876 |
| Contact | H Y Manlulu |
| Correspondent | H Y Manlulu BIOSEARCH MEDICAL PRODUCTS, INC. Somerville, NJ 08876 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-14 |
| Decision Date | 1983-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521518872 | K833621 | 000 |
| 10884521518810 | K833621 | 000 |