The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Trans/r - Fp(3).
Device ID | K900016 |
510k Number | K900016 |
Device Name: | TRANS/R - FP(3) |
Classification | Bulb, Inflation, For Endoscope |
Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
Contact | J Wedel |
Correspondent | J Wedel CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
Product Code | FCY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-06-11 |