The following data is part of a premarket notification filed by Medisiss with the FDA for Medisiss Reprocessed Non-electric Gi Biopsy Forceps.
| Device ID | K042659 |
| 510k Number | K042659 |
| Device Name: | MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric, Reprocessed |
| Applicant | MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Contact | Brandi James |
| Correspondent | Brandi James MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Product Code | NON |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2005-02-14 |
| Summary: | summary |