510(k) K810471
K810471 is an FDA 510(k) premarket notification submitted by Cathra International, Inc. for the device "STOCK ANTIMICROBIC SOLUTIONS". The FDA issued a decision of Substantially Equivalent on April 1, 1981. The device falls under product code LOP (Solution, Antimicrobial), a Class II device regulated under 21 CFR 866.1640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1981
- Date Received
- February 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solution, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type