The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Sterile X-ray Detectable Gauze Sponges.
| Device ID | K941522 |
| 510k Number | K941522 |
| Device Name: | STERILE X-RAY DETECTABLE GAUZE SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
| Contact | Steve B Johnson |
| Correspondent | Steve B Johnson CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE 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 | 1994-03-30 |
| Decision Date | 1994-05-12 |