The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Silicone Rubber Sheet.
| Device ID | K911503 |
| 510k Number | K911503 |
| Device Name: | EXMOOR SILICONE RUBBER SHEET |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Brian East |
| Correspondent | Brian East EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060180259242 | K911503 | 000 |
| 05060180251970 | K911503 | 000 |
| 05060180251987 | K911503 | 000 |
| 05060180251994 | K911503 | 000 |
| 05060180252007 | K911503 | 000 |
| 05060180252014 | K911503 | 000 |
| 05060180252021 | K911503 | 000 |
| 05060180252038 | K911503 | 000 |
| 05060180252045 | K911503 | 000 |
| 05060180252052 | K911503 | 000 |
| 05060180255152 | K911503 | 000 |
| 05060180254612 | K911503 | 000 |