The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Bari-ring, Model Ks-br-2005.
| Device ID | K050384 |
| 510k Number | K050384 |
| Device Name: | KAPP BARI-RING, MODEL KS-BR-2005 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Contact | Albert Santilli |
| Correspondent | Albert Santilli KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-15 |
| Decision Date | 2006-01-13 |
| Summary: | summary |