The following data is part of a premarket notification filed by Shawnee Products, Inc. with the FDA for Sponge, Laparotomy, Various Size.
| Device ID | K940436 |
| 510k Number | K940436 |
| Device Name: | SPONGE, LAPAROTOMY, VARIOUS SIZE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | SHAWNEE PRODUCTS, INC. 1201 HOLLY LANE, BLDG. #3 Tecumseh, OK 74873 |
| Contact | Earl L Little |
| Correspondent | Earl L Little SHAWNEE PRODUCTS, INC. 1201 HOLLY LANE, BLDG. #3 Tecumseh, OK 74873 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1994-07-26 |