510(k) K030525

CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES by Mid-Atlantic Diagnostics, Inc. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2003
Date Received
February 19, 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