The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Lockbox For Use With Cadd Solis Infusion Pump.
| Device ID | K080743 |
| 510k Number | K080743 |
| Device Name: | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586031901 | K080743 | 000 |
| 15019517139075 | K080743 | 000 |
| 15019517139068 | K080743 | 000 |
| 10610586035036 | K080743 | 000 |
| 10610586031878 | K080743 | 000 |
| 10610586042980 | K080743 | 000 |
| 10610586031243 | K080743 | 000 |