The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Heart-lift(tm) Cardiac Retraction Gloves-steri.
| Device ID | K882381 |
| 510k Number | K882381 |
| Device Name: | PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI |
| Classification | Surgeon's Gloves |
| Applicant | PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Contact | Wright,phd |
| Correspondent | Wright,phd PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-09 |
| Decision Date | 1988-07-07 |