The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd Medication Cassette Reservoir.
| Device ID | K081156 |
| 510k Number | K081156 |
| Device Name: | CADD MEDICATION CASSETTE RESERVOIR |
| Classification | Set, Administration, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-23 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586032398 | K081156 | 000 |
| 30610586032381 | K081156 | 000 |
| 30610586032374 | K081156 | 000 |