510(k) K052870
K052870 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200". The FDA issued a decision of Substantially Equivalent on September 29, 2006. The device falls under product code NZP (Sealant, Microbial), a Class II device regulated under 21 CFR 878.4370. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2006
- Date Received
- October 11, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Microbial
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type
Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.