K912103 is an FDA 510(k) clearance for the LIFESHIELD EXTENSION SET. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 13, 1991, 214 days after receiving the submission on May 13, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K912103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1991 |
| Decision Date | December 13, 1991 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |