510(k) K072942
K072942 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on February 8, 2008. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2008
- Date Received
- October 17, 2007
- 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