Submission Details
| 510(k) Number | K091133 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2009 |
| Decision Date | May 20, 2009 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
APLION TOPICAL CARE SYSTEM
May 2009
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K091133 is an FDA 510(k) clearance for the APLION TOPICAL CARE SYSTEM, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Aplion Medical,Llc (Salt Lake City, US). The FDA issued a Cleared decision on May 20, 2009, 30 days after receiving the submission on April 20, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.
Device Classification
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4020 |
Manufacturer
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