510(k) K980827
K980827 is an FDA 510(k) premarket notification submitted by Tucker & Associates for the device "LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING". The FDA issued a decision of Substantially Equivalent on May 4, 1998. The device falls under product code LZB (Finger Cot), a Class I device regulated under 21 CFR 880.6250. Tucker & Associates has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 1998
- Date Received
- March 3, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Finger Cot
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type