The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-tip Intraoperative Transducer Cover,.
| Device ID | K991236 |
| 510k Number | K991236 |
| Device Name: | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | J. William Jones |
| Correspondent | J. William Jones CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-06-02 |
| Summary: | summary |