ENDOTOME
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
BERKELEY BIO-ENGINEERING
The following data is part of a premarket notification filed by Berkeley Bio-engineering with the FDA for Endotome.
Pre-market Notification Details
| Device ID | K790645 |
| 510k Number | K790645 |
| Device Name: | ENDOTOME |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | BERKELEY BIO-ENGINEERING 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-30 |
| Decision Date | 1979-04-23 |
Trademark Results [ENDOTOME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOTOME 73536783 1393129 Dead/Cancelled |
CABOT MEDICAL CORPORATION 1985-05-10 |
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