The following data is part of a premarket notification filed by Frantz Medical Development, Ltd. with the FDA for Flexiflo Companion Enteral Nutrition Pump.
| Device ID | K873119 |
| 510k Number | K873119 |
| Device Name: | FLEXIFLO COMPANION ENTERAL NUTRITION PUMP |
| Classification | Pump, Infusion, Enteral |
| Applicant | FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Contact | Mark G Frantz |
| Correspondent | Mark G Frantz FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1987-11-05 |