The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Wang/mill-rose Transbronchial Aspiration Needle.
| Device ID | K914181 |
| 510k Number | K914181 |
| Device Name: | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Alan C Poje |
| Correspondent | Alan C Poje MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1991-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405052739 | K914181 | 000 |
| 10653405052654 | K914181 | 000 |
| 10653405052661 | K914181 | 000 |
| 10653405052678 | K914181 | 000 |
| 10653405052685 | K914181 | 000 |
| 10653405052692 | K914181 | 000 |
| 10653405052708 | K914181 | 000 |
| 10653405052715 | K914181 | 000 |
| 10653405052722 | K914181 | 000 |
| 10653405052647 | K914181 | 000 |