The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Lsi Videoscopic Display System.
Device ID | K963919 |
510k Number | K963919 |
Device Name: | LSI VIDEOSCOPIC DISPLAY SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
Contact | Jude S Sauer |
Correspondent | Jude S Sauer LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-30 |
Decision Date | 1997-01-08 |
Summary: | summary |