The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Changing Method Of Sterility Release.
| Device ID | K832368 |
| 510k Number | K832368 |
| Device Name: | CHANGING METHOD OF STERILITY RELEASE |
| Classification | Knife, Surgical |
| Applicant | DEVON INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-10-31 |