510(k) K122000
K122000 is an FDA 510(k) premarket notification submitted by Changzhou Holymed Products Co., Ltd. for the device "HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER". The FDA issued a decision of Substantially Equivalent on December 12, 2012. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Changzhou Holymed Products Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2012
- Date Received
- July 9, 2012
- 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.