The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Semperflo Infusion System.
| Device ID | K052999 |
| 510k Number | K052999 |
| Device Name: | SEMPERFLO INFUSION SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
| Contact | Jennifer M Paine |
| Correspondent | Jennifer M Paine ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-25 |
| Decision Date | 2006-03-22 |
| Summary: | summary |