The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Instruments For Laparoscopic Use.
Device ID | K931142 |
510k Number | K931142 |
Device Name: | INSTRUMENTS FOR LAPAROSCOPIC USE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LI MEDICAL TECHNOLOGIES, INC. 7 CASTLE COURT Greenwich, CT 06830 |
Contact | Rhodemann Li |
Correspondent | Rhodemann Li LI MEDICAL TECHNOLOGIES, INC. 7 CASTLE COURT Greenwich, CT 06830 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-05 |
Decision Date | 1993-06-25 |