K770498 is an FDA 510(k) clearance for the PRESERVE LUBRICANT CODE NO. 43=4035. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1977, 98 days after receiving the submission on March 14, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K770498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1977 |
| Decision Date | June 20, 1977 |
| Days to Decision | 98 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 |