The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Laporascopic Cannula Seal.
Device ID | K933025 |
510k Number | K933025 |
Device Name: | LAPORASCOPIC CANNULA SEAL |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LI MEDICAL TECHNOLOGIES, INC. 7 CASTLE COURT Greenwich, CT 06830 |
Contact | Lehman Li |
Correspondent | Lehman 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 | 1993-06-22 |
Decision Date | 1994-01-25 |