The following data is part of a premarket notification filed by Inrad with the FDA for Ultraclip Tissue Marker.
| Device ID | K993785 |
| 510k Number | K993785 |
| Device Name: | ULTRACLIP TISSUE MARKER |
| Classification | Staple, Implantable |
| Applicant | INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Contact | Joseph M Mazurek |
| Correspondent | Joseph M Mazurek INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 2000-02-04 |
| Summary: | summary |