The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Jarit, Ruggles, R&b Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs.
| Device ID | K092227 |
| 510k Number | K092227 |
| Device Name: | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS |
| Classification | Rongeur, Manual |
| Applicant | INTEGRA LIFESCIENCES CORP. 589 DAVIES DR. York, PA 17402 |
| Contact | Jennifer Bosley |
| Correspondent | Jennifer Bosley INTEGRA LIFESCIENCES CORP. 589 DAVIES DR. York, PA 17402 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834MH263971 | K092227 | 000 |