K864556 is an FDA 510(k) clearance for the AQUALUBE(TM). This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on December 1, 1986, 12 days after receiving the submission on November 19, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K864556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1986 |
| Decision Date | December 01, 1986 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KMJ — Lubricant, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6375 |