Steribite
Rongeur, Manual
RJR Surgical, Inc.
The following data is part of a premarket notification filed by Rjr Surgical, Inc. with the FDA for Steribite.
Pre-market Notification Details
| Device ID | K180949 |
| 510k Number | K180949 |
| Device Name: | Steribite |
| Classification | Rongeur, Manual |
| Applicant | RJR Surgical, Inc. 2530 Superior Avenue Cleveland, OH 44114 |
| Contact | John Redmond |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 -0566 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-11 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
Trademark Results [Steribite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERIBITE 86598180 4999534 Live/Registered |
STERIBITE, LLC 2015-04-15 |
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