510(k) K890734
K890734 is an FDA 510(k) premarket notification submitted by Microcopy, Div. Neo-Flo, Inc. for the device "DRY TIPS". The FDA issued a decision of Substantially Equivalent on March 10, 1989. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Microcopy, Div. Neo-Flo, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1989
- Date Received
- February 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorber, Saliva, Paper
- Device Class
- Class I
- Regulation Number
- 872.6050
- Review Panel
- DE
- Submission Type