The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Trans Vaginal Needle Guide.
| Device ID | K971722 |
| 510k Number | K971722 |
| Device Name: | TRANS VAGINAL NEEDLE GUIDE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Contact | Rick L Pruter |
| Correspondent | Rick L Pruter PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841912101495 | K971722 | 000 |
| 00841912102402 | K971722 | 000 |
| 00841912102396 | K971722 | 000 |