The following data is part of a premarket notification filed by Aplion Medical,llc with the FDA for Aplion Topical Care System.
| Device ID | K091133 |
| 510k Number | K091133 |
| Device Name: | APLION TOPICAL CARE SYSTEM |
| Classification | Dressing, Wound, Occlusive |
| Applicant | APLION MEDICAL,LLC 2425 SOUTH 900 WEST Salt Lake City, UT 84119 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen APLION MEDICAL,LLC 2425 SOUTH 900 WEST Salt Lake City, UT 84119 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-05-20 |
| Summary: | summary |