The following data is part of a premarket notification filed by Interson Corp. with the FDA for Biopsy Needle Guide For Adms Ultrasound Probes.
| Device ID | K895725 |
| 510k Number | K895725 |
| Device Name: | BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES |
| Classification | Biopsy Needle |
| Applicant | INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Contact | Mark F Hayward |
| Correspondent | Mark F Hayward INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-11-06 |