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 |