510(k) K011481

10% PVP; 10% PVP IN EBSS SOLUTION by Conception Technologies — Product Code MQL

K011481 is an FDA 510(k) premarket notification submitted by Conception Technologies for the device "10% PVP; 10% PVP IN EBSS SOLUTION". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Conception Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2001
Date Received
May 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type