510(k) K862062
K862062 is an FDA 510(k) premarket notification submitted by East Texas Lighthouse For the Blind for the device "NONWOVEN SURGICAL DRAPE PACK". The FDA issued a decision of Substantially Equivalent on June 10, 1986. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. East Texas Lighthouse For the Blind has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1986
- Date Received
- May 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Surgical, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.