The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Trans/p Needle Guide.
| Device ID | K875236 |
| 510k Number | K875236 |
| Device Name: | TRANS/P NEEDLE GUIDE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Contact | Victor Wedel |
| Correspondent | Victor Wedel CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436122870 | K875236 | 000 |
| 00841436122863 | K875236 | 000 |
| 00841436125307 | K875236 | 000 |