The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-art (tm) Pick-up Wicks.
| Device ID | K905068 |
| 510k Number | K905068 |
| Device Name: | PTI INTRA-ART (TM) PICK-UP WICKS |
| Classification | Gauze/sponge, Internal |
| Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Wright |
| Correspondent | Wright PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-09 |
| Decision Date | 1991-12-31 |