The following data is part of a premarket notification filed by Lsvp Intl., Inc. with the FDA for Lsvp International Grasping Forceps.
Device ID | K945295 |
510k Number | K945295 |
Device Name: | LSVP INTERNATIONAL GRASPING FORCEPS |
Classification | Dislodger, Stone, Biliary |
Applicant | LSVP INTL., INC. 12755 ALTO VERDE LN. Los Altos Hills, CA 94022 |
Contact | Sophia Pesotchinsky |
Correspondent | Sophia Pesotchinsky LSVP INTL., INC. 12755 ALTO VERDE LN. Los Altos Hills, CA 94022 |
Product Code | LQR |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-31 |
Decision Date | 1995-03-08 |