The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Rongeur.
Device ID | K081651 |
510k Number | K081651 |
Device Name: | INSTRUMED RONGEUR |
Classification | Rongeur, Manual |
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 | HAE |
CFR Regulation Number | 882.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-12 |
Decision Date | 2008-08-08 |
Summary: | summary |