The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Fiber Optic Light Guide #60-0767.
Device ID | K802773 |
510k Number | K802773 |
Device Name: | FIBER OPTIC LIGHT GUIDE #60-0767 |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-03 |
Decision Date | 1980-12-16 |