The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Lmt Arthroscopic Suturing Instruments.
Device ID | K941964 |
510k Number | K941964 |
Device Name: | LMT ARTHROSCOPIC SUTURING INSTRUMENTS |
Classification | Arthroscope |
Applicant | LI MEDICAL TECHNOLOGIES, INC. 12 CAMBRIDGE DR. Trumbull, CT 06611 |
Contact | Rhodemann Li |
Correspondent | Rhodemann Li LI MEDICAL TECHNOLOGIES, INC. 12 CAMBRIDGE DR. Trumbull, CT 06611 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1994-09-28 |