The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Retractors.
Device ID | K071771 |
510k Number | K071771 |
Device Name: | INSTRUMED RETRACTORS |
Classification | Retractor, Self-retaining, For Neurosurgery |
Applicant | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
Contact | Michael Massong |
Correspondent | Michael Massong INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
Product Code | GZT |
CFR Regulation Number | 882.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-29 |
Decision Date | 2007-08-02 |
Summary: | summary |