510(k) K050797
K050797 is an FDA 510(k) premarket notification submitted by Shippert Medical Technologies Corp. for the device "TISSU-TRANS". The FDA issued a decision of Substantially Equivalent on July 13, 2005. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Shippert Medical Technologies Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2005
- Date Received
- March 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type