The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Sterile Gauze Product Line.
| Device ID | K941455 |
| 510k Number | K941455 |
| Device Name: | STERILE GAUZE PRODUCT LINE |
| Classification | Gauze/sponge, Internal |
| Applicant | CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
| Contact | Steve B Johnston |
| Correspondent | Steve B Johnston CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-25 |
| Decision Date | 1994-05-20 |