510(k) K941035
K941035 is an FDA 510(k) premarket notification submitted by Trinity Partners, LLC for the device "VENOSCOPE". The FDA issued a decision of Substantially Equivalent on May 16, 1994. The device falls under product code HJN (Transilluminator, Battery-Powered), a Class I device regulated under 21 CFR 886.1945.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1994
- Date Received
- March 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transilluminator, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1945
- Review Panel
- OP
- Submission Type