Submission Details
| 510(k) Number | K920306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 1992 |
| Decision Date | April 06, 1992 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
K920306 is an FDA 510(k) clearance for the OPTI-MOL FILTERED PUNCTURE PIN, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 6, 1992, 75 days after receiving the submission on January 22, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K920306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 1992 |
| Decision Date | April 06, 1992 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5450 |