The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Accuflow And Accuflux Elastomeric Infusion Pump.
| Device ID | K081905 |
| 510k Number | K081905 |
| Device Name: | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | Westmed, Inc. 3957 BLUE PINE CIRCLE Highlands Ranch, CO 80126 -8077 |
| Contact | Charles M Hart |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-07-15 |
| Summary: | summary |