510(k) K983716
K983716 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "VITALCARE DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on Dec 23, 1998. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 1998
- Date Received
- Oct 21, 1998
- 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