510(k) K101689
K101689 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing, Inc. for the device "EMM EQUIPMENT COVER-POLYTHYLENE". The FDA issued a decision of Substantially Equivalent on Sep 20, 2010. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Exact Medical Manufacturing, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 20, 2010
- Date Received
- Jun 16, 2010
- 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
- 510(k)
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.