The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Lap Sponge Product Line.
| Device ID | K941344 |
| 510k Number | K941344 |
| Device Name: | LAP SPONGE PRODUCT LINE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | CUSH MEDICAL PRODUCTS 881 MOUNTAIN VIEW DR. Piney Flats, TN 37686 |
| Contact | Steve B Johnston |
| Correspondent | Steve B Johnston CUSH MEDICAL PRODUCTS 881 MOUNTAIN VIEW DR. Piney Flats, TN 37686 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-05-12 |