K013820 is an FDA 510(k) clearance for the FINN CHAMBER (R). This device is classified as a Applicator, Absorbent Tipped, Non-sterile (Class I - General Controls, product code KXF).
Submitted by Epitest Ltd. OY (Petaluma, US). The FDA issued a Cleared decision on January 30, 2002, 75 days after receiving the submission on November 16, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6025.
| 510(k) Number | K013820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2001 |
| Decision Date | January 30, 2002 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KXF — Applicator, Absorbent Tipped, Non-sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6025 |