The following data is part of a premarket notification filed by Reichert Scientific Instruments with the FDA for Modular Fiberscope System.
Device ID | K843683 |
510k Number | K843683 |
Device Name: | MODULAR FIBERSCOPE SYSTEM |
Classification | Endoscope, Ac-powered And Accessories |
Applicant | REICHERT SCIENTIFIC INSTRUMENTS 201 TABOR ROAD BLDG 7 Morris Plains , NJ 07950 - |
Contact | Albert P Seprinski |
Correspondent | Albert P Seprinski REICHERT SCIENTIFIC INSTRUMENTS 201 TABOR ROAD BLDG 7 Morris Plains , NJ 07950 - |
Product Code | GCP |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-18 |
Decision Date | 1985-01-18 |