The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for 'exmoor' Das Gupta Laryngeal Keel.
| Device ID | K864936 |
| 510k Number | K864936 |
| Device Name: | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL |
| Classification | Prosthesis, Larynx (stents And Keels) |
| 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 | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-16 |
| Decision Date | 1987-04-27 |