The following data is part of a premarket notification filed by I M, Inc. with the FDA for Biopsy Kit.
| Device ID | K892389 |
| 510k Number | K892389 |
| Device Name: | BIOPSY KIT |
| Classification | General Surgery Tray |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Amir Porat |
| Correspondent | Amir Porat I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-07-17 |