510(k) K802280
K802280 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "WHITE KNIGHT DRAPE SEAL". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1980
- Date Received
- September 18, 1980
- 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.