The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Tissu-trans.
| Device ID | K050797 |
| 510k Number | K050797 |
| Device Name: | TISSU-TRANS |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
| Contact | Sarah Lake |
| Correspondent | Sarah Lake 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-29 |
| Decision Date | 2005-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TISSU-TRANS 78640476 3160819 Live/Registered |
SHIPPERT ENTERPRISES, LLC 2005-05-31 |