The following data is part of a premarket notification filed by Cardinal Health with the FDA for Occlusion Detection Dressing Kit.
| Device ID | K171499 |
| 510k Number | K171499 |
| Device Name: | Occlusion Detection Dressing Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Cardinal Health 1500 S Waukegan Rd Waukegan, IL 60085 |
| Contact | Beth Foster |
| Correspondent | Beth Foster Cardinal Health 1500 S Waukegan Rd Waukegan, IL 60085 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-23 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380153141 | K171499 | 000 |