K893766 is an FDA 510(k) clearance for the LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE. This device is classified as a Catheter, Percutaneous, Intraspinal, Short Term (Class II - Special Controls, product code MAJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 1, 1989, 166 days after receiving the submission on May 19, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K893766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1989 |
| Decision Date | November 01, 1989 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | MAJ — Catheter, Percutaneous, Intraspinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |