The following data is part of a premarket notification filed by Interson Corp. with the FDA for Interson Disposable Biopsy Needle.
| Device ID | K911464 |
| 510k Number | K911464 |
| Device Name: | INTERSON DISPOSABLE BIOPSY NEEDLE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Contact | Michael Christy |
| Correspondent | Michael Christy INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-09-27 |