510(k) K882054
K882054 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "HYSTERO KIT". The FDA issued a decision of Substantially Equivalent on September 29, 1988. The device falls under product code HDP (Elevator, Uterine), a Class II device regulated under 21 CFR 884.4530. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1988
- Date Received
- May 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type