510(k) K900208
K900208 is an FDA 510(k) premarket notification submitted by Zerowet Splashield for the device "ZEROWET SPLASHIELD". The FDA issued a decision of Substantially Equivalent on Sep 4, 1990. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 4, 1990
- Date Received
- Jan 17, 1990
- 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
- 510(k) Exempt