The following data is part of a premarket notification filed by Levtech, Inc. with the FDA for Levtech Composite Traction Tongs.
Device ID | K873693 |
510k Number | K873693 |
Device Name: | LEVTECH COMPOSITE TRACTION TONGS |
Classification | Tong, Skull For Traction |
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 | HAX |
CFR Regulation Number | 882.5960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1988-02-05 |