The following data is part of a premarket notification filed by Interson Corp. with the FDA for Probe Sheath For Adms & Capistrano Labs Transrec..
| Device ID | K896680 |
| 510k Number | K896680 |
| Device Name: | PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| 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 | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-02-14 |