The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for On-q Pain Relief System, Quikbloc Over-the-needle Catheter Set.
| Device ID | K143164 |
| 510k Number | K143164 |
| Device Name: | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | KIMBERLY-CLARK CORPORATION 43 DISCOVERY, SUITE 100 Irvine, CA 92618 |
| Contact | Maria E Wagner |
| Correspondent | Maria E Wagner KIMBERLY-CLARK CORPORATION 43 DISCOVERY, SUITE 100 Irvine, CA 92618 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2014-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494449299 | K143164 | 000 |
| 10193494449282 | K143164 | 000 |
| 10193494449275 | K143164 | 000 |
| 10193494449268 | K143164 | 000 |
| 10193494430594 | K143164 | 000 |
| 10193494430587 | K143164 | 000 |
| 10193494430570 | K143164 | 000 |
| 10193494430563 | K143164 | 000 |