K830571 is an FDA 510(k) clearance for the BOTTLE ADAPTER. This device is classified as a Dispenser, Liquid Medication (Class I - General Controls, product code KYX).
Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 29 days after receiving the submission on February 23, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6430.
| 510(k) Number | K830571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1983 |
| Decision Date | March 24, 1983 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KYX — Dispenser, Liquid Medication |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6430 |