The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Fibeo Optics Illum. System.
Device ID | K771918 |
510k Number | K771918 |
Device Name: | FIBEO OPTICS ILLUM. SYSTEM |
Classification | Endoscope, Ac-powered And Accessories |
Applicant | PROPPER MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCP |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-12 |
Decision Date | 1977-10-20 |