K020586 is an FDA 510(k) clearance for the GOOD LUBRICATIONS. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on January 24, 2003, 336 days after receiving the submission on February 22, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K020586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2002 |
| Decision Date | January 24, 2003 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KMJ - Lubricant, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6375 |