The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Bari-ring Endoscopic Marker, Model K-9536.
| Device ID | K072216 |
| 510k Number | K072216 |
| Device Name: | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Contact | Albert N Santilli |
| Correspondent | Albert N 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-09 |
| Decision Date | 2007-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B033K9536N0 | K072216 | 000 |