K911503 is an FDA 510(k) clearance for the EXMOOR SILICONE RUBBER SHEET. This device is classified as a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II - Special Controls, product code KHJ).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on November 19, 1991, 230 days after receiving the submission on April 3, 1991.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K911503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1991 |
| Decision Date | November 19, 1991 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |