510(k) K030693
K030693 is an FDA 510(k) premarket notification submitted by Kentron Health Care, Inc. for the device "KENTEX DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on August 27, 2003. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Kentron Health Care, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2003
- Date Received
- March 5, 2003
- 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