510(k) K113268
K113268 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "ALEXIS O WOUND PROTECTOR/RETRACTOR". The FDA issued a decision of Substantially Equivalent on February 8, 2013. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2013
- Date Received
- November 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring (Wound Protector), Drape Retention, Internal
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- SU
- Submission Type