510(k) K954824
K954824 is an FDA 510(k) premarket notification submitted by Medical Creative Technologies, Inc. for the device "PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE". The FDA issued a decision of Substantially Equivalent on April 23, 1996. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Medical Creative Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1996
- Date Received
- October 20, 1995
- 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.