510(k) K040717

NUNC IVF MULTIDISH 4 WELLS NUNCLON by Nunc A/S — Product Code MQK

K040717 is an FDA 510(k) premarket notification submitted by Nunc A/S for the device "NUNC IVF MULTIDISH 4 WELLS NUNCLON". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Nunc A/S has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2004
Date Received
March 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type