The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Choledochofiberscope, #fcd-15a.
Device ID | K821974 |
510k Number | K821974 |
Device Name: | PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A |
Classification | Choledochoscope And Accessories, Flexible/rigid |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FBN |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-02 |
Decision Date | 1982-08-10 |