The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Lockbox For Use With Medfusion 3000 Series Pumps.
| Device ID | K091181 |
| 510k Number | K091181 |
| Device Name: | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS |
| Classification | Accessories, Pump, Infusion |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | James Chapman |
| Correspondent | James Chapman SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586031489 | K091181 | 000 |