510(k) K082349
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