The following data is part of a premarket notification filed by Blazejewski Medi-tech Gmbh with the FDA for Spinal Foraminoscope.
| Device ID | K082841 |
| 510k Number | K082841 |
| Device Name: | SPINAL FORAMINOSCOPE |
| Classification | Arthroscope |
| Applicant | BLAZEJEWSKI MEDI-TECH GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp BLAZEJEWSKI MEDI-TECH GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2009-09-09 |
| Summary: | summary |