The following data is part of a premarket notification filed by Parkermedicalinc with the FDA for Parker Flex- Tip Oral/nasa Intubation Tube.
| Device ID | K100546 |
| 510k Number | K100546 |
| Device Name: | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | PARKERMEDICALINC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward PARKERMEDICALINC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20607411954607 | K100546 | 000 |
| 00607411954474 | K100546 | 000 |
| 20607411954461 | K100546 | 000 |
| 20607411954454 | K100546 | 000 |
| 20607411954447 | K100546 | 000 |
| 20607411954430 | K100546 | 000 |
| 20607411954423 | K100546 | 000 |
| 20607411954416 | K100546 | 000 |
| 20607411954409 | K100546 | 000 |
| 10607411954396 | K100546 | 000 |
| 20607411954386 | K100546 | 000 |
| 20607411954485 | K100546 | 000 |
| 20607411954492 | K100546 | 000 |
| 20607411954591 | K100546 | 000 |
| 20607411954584 | K100546 | 000 |
| 20607411954577 | K100546 | 000 |
| 20607411954560 | K100546 | 000 |
| 20607411954553 | K100546 | 000 |
| 20607411654545 | K100546 | 000 |
| 20607411954539 | K100546 | 000 |
| 20607411954522 | K100546 | 000 |
| 20607411954515 | K100546 | 000 |
| 20607411954508 | K100546 | 000 |
| 20607411954379 | K100546 | 000 |