The following data is part of a premarket notification filed by Frantz Medical Development, Ltd. with the FDA for Clearstar Enteral Nutrition Pump.
| Device ID | K981541 |
| 510k Number | K981541 |
| Device Name: | CLEARSTAR ENTERAL NUTRITION PUMP |
| Classification | Pump, Infusion, Enteral |
| Applicant | FRANTZ MEDICAL DEVELOPMENT, LTD. 7740 METRIC DR. Mentor, OH 44060 |
| Contact | J P Hanson |
| Correspondent | J P Hanson FRANTZ MEDICAL DEVELOPMENT, LTD. 7740 METRIC DR. Mentor, OH 44060 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1998-08-13 |
| Summary: | summary |