The following data is part of a premarket notification filed by Lsvp Intl., Inc. with the FDA for Lsvp International Hot Biopsy Forceps.
Device ID | K971204 |
510k Number | K971204 |
Device Name: | LSVP INTERNATIONAL HOT BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Electric |
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 | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-01 |
Decision Date | 1997-05-27 |
Summary: | summary |