The following data is part of a premarket notification filed by Hne Healthcare, Inc. with the FDA for Flowtron Excel Pump.
| Device ID | K961166 |
| 510k Number | K961166 |
| Device Name: | FLOWTRON EXCEL PUMP |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-25 |
| Decision Date | 1996-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055982700016 | K961166 | 000 |
| 15055982700884 | K961166 | 000 |
| 15055982700860 | K961166 | 000 |
| 15055982700723 | K961166 | 000 |
| 15055982700709 | K961166 | 000 |
| 15055982700693 | K961166 | 000 |
| 15055982700679 | K961166 | 000 |