K840107 is an FDA 510(k) clearance for the TUBE-BANDAGE FOR HUMAN DIGITS 200. This device is classified as a Bandage, Elastic (Class I - General Controls, product code FQM).
Submitted by Zens Health Care Products (Walker, US). The FDA issued a Cleared decision on April 25, 1984, 106 days after receiving the submission on January 10, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5075.
| 510(k) Number | K840107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1984 |
| Decision Date | April 25, 1984 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FQM — Bandage, Elastic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5075 |