510(k) K820962
K820962 is an FDA 510(k) premarket notification submitted by Dafoe & Dafoe, Inc. for the device "COTTON SWABS". The FDA issued a decision of Substantially Equivalent on April 20, 1982. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Dafoe & Dafoe, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1982
- Date Received
- April 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Absorbent Tipped, Non-Sterile
- Device Class
- Class I
- Regulation Number
- 880.6025
- Review Panel
- HO
- Submission Type