The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Donaldson/shepards Dr/collar/shah Vent-mini Tubes.
| Device ID | K911580 |
| 510k Number | K911580 |
| Device Name: | DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES |
| Classification | Tube, Tympanostomy |
| 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 | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060180255800 | K911580 | 000 |
| 05060180251468 | K911580 | 000 |
| 05060180251475 | K911580 | 000 |
| 05060180251482 | K911580 | 000 |
| 05060180251499 | K911580 | 000 |
| 05060180251505 | K911580 | 000 |
| 05060180251512 | K911580 | 000 |
| 05060180251529 | K911580 | 000 |
| 05060180251536 | K911580 | 000 |
| 05060180251451 | K911580 | 000 |
| 05060180251444 | K911580 | 000 |
| 05060180251413 | K911580 | 000 |
| 05060180251338 | K911580 | 000 |
| 05060180251345 | K911580 | 000 |
| 05060180255831 | K911580 | 000 |
| 05060180251369 | K911580 | 000 |
| 05060180251376 | K911580 | 000 |
| 05060180251383 | K911580 | 000 |
| 05060180251390 | K911580 | 000 |
| 05060180251406 | K911580 | 000 |
| 05060180251543 | K911580 | 000 |
| 05060180251550 | K911580 | 000 |
| 05060180251710 | K911580 | 000 |
| 05060180251727 | K911580 | 000 |
| 05060180251734 | K911580 | 000 |
| 05060180251741 | K911580 | 000 |
| 05060180251758 | K911580 | 000 |
| 05060180254469 | K911580 | 000 |
| 05060180251765 | K911580 | 000 |
| 05060180251772 | K911580 | 000 |
| 05060180251703 | K911580 | 000 |
| 05060180251697 | K911580 | 000 |
| 05060180251680 | K911580 | 000 |
| 05060180251567 | K911580 | 000 |
| 05060180251598 | K911580 | 000 |
| 05060180251604 | K911580 | 000 |
| 05060180251611 | K911580 | 000 |
| 05060180251628 | K911580 | 000 |
| 05060180251635 | K911580 | 000 |
| 05060180251666 | K911580 | 000 |
| 05060180251673 | K911580 | 000 |
| 05060180254452 | K911580 | 000 |