510(k) K900822
K900822 is an FDA 510(k) premarket notification submitted by National-Standard Medical Products for the device "HYDRO-SIL(TM) COATED GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on July 17, 1990. The device falls under product code DOX (Fluorometer, Lead (Dedicated Instruments)), a Class II device regulated under 21 CFR 862.3550. National-Standard Medical Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1990
- Date Received
- February 21, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometer, Lead (Dedicated Instruments)
- Device Class
- Class II
- Regulation Number
- 862.3550
- Review Panel
- TX
- Submission Type