The following data is part of a premarket notification filed by Hoogland Spine Products Gmbh with the FDA for Maxmorespine Tom Stick.
Device ID | K083552 |
510k Number | K083552 |
Device Name: | MAXMORESPINE TOM STICK |
Classification | Arthroscope |
Applicant | HOOGLAND SPINE PRODUCTS GMBH ARABELLASTR 4 Muenchen, DE D-81925 |
Contact | Boris Miklitz |
Correspondent | Boris Miklitz HOOGLAND SPINE PRODUCTS GMBH ARABELLASTR 4 Muenchen, DE D-81925 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-01 |
Decision Date | 2009-10-09 |
Summary: | summary |