510(k) K923656
K923656 is an FDA 510(k) premarket notification submitted by Galenica Enterprises, Inc. for the device "LIGHTING SOURCE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 1994. The device falls under product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic), a Class II device regulated under 21 CFR 884.4530. Galenica Enterprises, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1994
- Date Received
- July 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type