The following data is part of a premarket notification filed by Posey Co. with the FDA for Posey Cufflator.
| Device ID | K912723 |
| 510k Number | K912723 |
| Device Name: | POSEY CUFFLATOR |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | POSEY CO. 2443 DELTA LN. Elk Grove Village, IL 60007 |
| Contact | Ernest M Posey |
| Correspondent | Ernest M Posey POSEY CO. 2443 DELTA LN. Elk Grove Village, IL 60007 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-19 |
| Decision Date | 1991-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05707480133086 | K912723 | 000 |
| B005001970 | K912723 | 000 |
| B00500197TUBING0 | K912723 | 000 |
| 14026704630513 | K912723 | 000 |
| 04250105600469 | K912723 | 000 |
| 04250105600476 | K912723 | 000 |
| 04250105600483 | K912723 | 000 |
| 04250105600513 | K912723 | 000 |
| 04250105605723 | K912723 | 000 |
| 04250105622430 | K912723 | 000 |
| 04250105628098 | K912723 | 000 |
| 04250105604290 | K912723 | 000 |
| 14250105628088 | K912723 | 000 |
| 10862229000202 | K912723 | 000 |