510(k) K781098
K781098 is an FDA 510(k) premarket notification submitted by 3M Company for the device "BRUSH, APPLICATOR". The FDA issued a decision of Substantially Equivalent on September 29, 1978. The device falls under product code KXR (Applicator, Resin), a Class I device regulated under 21 CFR 872.3140. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1978
- Date Received
- July 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Resin
- Device Class
- Class I
- Regulation Number
- 872.3140
- Review Panel
- DE
- Submission Type