The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Tissu Trans Harvest Tubing.
| Device ID | K092022 |
| 510k Number | K092022 |
| Device Name: | TISSU TRANS HARVEST TUBING |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
| Contact | Sarah L Shippert |
| Correspondent | Sarah L Shippert SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-08-17 |