510(k) K880384
K880384 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code BWP (Shoe And Shoe Cover, Conductive), a Class I device regulated under 21 CFR 878.4040. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1988
- Date Received
- January 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoe And Shoe Cover, Conductive
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- SU
- Submission Type