The following data is part of a premarket notification filed by Levtech, Inc. with the FDA for Levtech Clamp Applier.
Device ID | K874023 |
510k Number | K874023 |
Device Name: | LEVTECH CLAMP APPLIER |
Classification | Forceps |
Applicant | LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
Contact | Levon Pentecost |
Correspondent | Levon Pentecost LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
Product Code | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-02 |
Decision Date | 1987-11-06 |