The following data is part of a premarket notification filed by Lares Manufacturing Co., Inc. with the FDA for Fiber Optic Hose.
Device ID | K801592 |
510k Number | K801592 |
Device Name: | FIBER OPTIC HOSE |
Classification | Light, Fiber Optic, Dental |
Applicant | LARES MANUFACTURING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAY |
CFR Regulation Number | 872.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-11 |
Decision Date | 1980-07-21 |