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 |