510(k) K000444
K000444 is an FDA 510(k) premarket notification submitted by Prism Enterprises, Inc. for the device "MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM". The FDA issued a decision of Substantially Equivalent on April 21, 2000. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Prism Enterprises, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2000
- Date Received
- February 10, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type