The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Devon Sponge Counter Bags.
| Device ID | K912824 |
| 510k Number | K912824 |
| Device Name: | DEVON SPONGE COUNTER BAGS |
| Classification | Counter, Sponge, Surgical |
| Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
| Contact | Rudy Gaba |
| Correspondent | Rudy Gaba DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1991-08-26 |