510(k) K082349

JARIT HULKA UTERINE TENACULUM FORCEPS by J. Jamner Surgical Instruments, Inc. — Product Code HDC

K082349 is an FDA 510(k) premarket notification submitted by J. Jamner Surgical Instruments, Inc. for the device "JARIT HULKA UTERINE TENACULUM FORCEPS". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. J. Jamner Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
August 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type