The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Sternal Closure Wire Suture.
| Device ID | K910067 |
| 510k Number | K910067 |
| Device Name: | PTI STERNAL CLOSURE WIRE SUTURE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| 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 | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-05-06 |