The following data is part of a premarket notification filed by Progressive Medical, Inc. with the FDA for Percutaneous Introducer Needle.
| Device ID | K191295 |
| 510k Number | K191295 |
| Device Name: | Percutaneous Introducer Needle |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Progressive Medical, Inc. 997 Horan Dr. Fenton, MO 63026 |
| Contact | Roland D. Sullivan |
| Correspondent | David W. Mullis Mullis & Associates, Inc. 367 Pleasant Valley Rd., P.O. Box 39 Good Hope, GA 30641 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2019-08-06 |