The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Sponge Counter.
| Device ID | K790538 |
| 510k Number | K790538 |
| Device Name: | SPONGE COUNTER |
| Classification | Counter, Sponge, Surgical |
| Applicant | DEVON INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-20 |
| Decision Date | 1979-04-04 |