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 |