The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Lmt Bone Anchor.
Device ID | K953764 |
510k Number | K953764 |
Device Name: | LMT BONE ANCHOR |
Classification | Staple, Fixation, Bone |
Applicant | LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
Contact | Rhodemann Li |
Correspondent | Rhodemann Li LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-11 |
Decision Date | 1995-08-25 |