The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Endotome Pneumatic Orthopaedic Cut.
| Device ID | K840831 |
| 510k Number | K840831 |
| Device Name: | ENDOTOME PNEUMATIC ORTHOPAEDIC CUT |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | CABOT MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-04 |