510(k) K000950

EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 by Labotect Labor-Technik Gottingen — Product Code MQF

K000950 is an FDA 510(k) premarket notification submitted by Labotect Labor-Technik Gottingen for the device "EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201". The FDA issued a decision of Substantially Equivalent on May 12, 2000. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Labotect Labor-Technik Gottingen has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
March 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type