The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Trans/r Needle Guide.
| Device ID | K875128 |
| 510k Number | K875128 |
| Device Name: | TRANS/R NEEDLE GUIDE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Contact | Victor J Wedel |
| Correspondent | Victor J 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 | 1987-12-15 |
| Decision Date | 1988-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841436114763 | K875128 | 000 |
| 00841436100496 | K875128 | 000 |
| 00841436100472 | K875128 | 000 |
| 00841436100434 | K875128 | 000 |
| 00841436100410 | K875128 | 000 |
| 00841436100366 | K875128 | 000 |
| 00841436100229 | K875128 | 000 |
| 00841436100144 | K875128 | 000 |
| 00841436100083 | K875128 | 000 |
| 00841436100076 | K875128 | 000 |
| 00841436111973 | K875128 | 000 |
| 00841436113700 | K875128 | 000 |
| 00841436118293 | K875128 | 000 |
| 20841436121426 | K875128 | 000 |
| 00841436101615 | K875128 | 000 |
| 00841436102025 | K875128 | 000 |
| 20841436114084 | K875128 | 000 |
| 20841436114077 | K875128 | 000 |
| 00841436110570 | K875128 | 000 |
| 00841436109932 | K875128 | 000 |
| 00841436107914 | K875128 | 000 |
| 00841436106801 | K875128 | 000 |
| 00841436106658 | K875128 | 000 |
| 00841436106603 | K875128 | 000 |
| 00841436106085 | K875128 | 000 |
| 00841436106078 | K875128 | 000 |
| 00841436104951 | K875128 | 000 |
| 00841436104906 | K875128 | 000 |
| 00841436103954 | K875128 | 000 |
| 20841436121518 | K875128 | 000 |