510(k) K000433

PBN HYSTERO-SALPINGOGRAPHY CATHETER SET by Medical Device Technologies, Inc. — Product Code LKF

K000433 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "PBN HYSTERO-SALPINGOGRAPHY CATHETER SET". The FDA issued a decision of Substantially Equivalent on June 16, 2000. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2000
Date Received
February 9, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type