510(k) K032086
K032086 is an FDA 510(k) premarket notification submitted by Planer Plc for the device "KRYO ART CONTROLLED RATE FREEZER". The FDA issued a decision of Substantially Equivalent on March 19, 2004. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Planer Plc has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2004
- Date Received
- July 7, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type