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 |