The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Deans Disposable T-tube Inserter.
| Device ID | K924901 |
| 510k Number | K924901 |
| Device Name: | DEANS DISPOSABLE T-TUBE INSERTER |
| Classification | Inserter, Myringotomy Tube |
| 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 | JYM |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-09 |
| Decision Date | 1993-01-28 |