510(k) K062907
K062907 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "ALEXIS WOUND RETRACTOR". The FDA issued a decision of Substantially Equivalent on January 9, 2007. 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 has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2007
- Date Received
- September 27, 2006
- 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