510(k) K945295
K945295 is an FDA 510(k) premarket notification submitted by Lsvp Intl., Inc. for the device "LSVP INTERNATIONAL GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Lsvp Intl., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1995
- Date Received
- October 31, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type