510(k) K102864
K102864 is an FDA 510(k) premarket notification submitted by Lac Mac, Ltd. for the device "84E SERIES SINGLE PLY WRAPPER". The FDA issued a decision of Substantially Equivalent on Jan 14, 2011. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Lac Mac, Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2011
- Date Received
- Sep 30, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type
- 510(k)