The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Rotorblade.
Device ID | K983435 |
510k Number | K983435 |
Device Name: | ROTORBLADE |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
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 | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-29 |
Decision Date | 1999-04-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROTORBLADE 75501803 not registered Dead/Abandoned |
Li Medical Technologies, Inc. 1998-06-15 |