The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Cush Island Dressing.
Device ID | K943424 |
510k Number | K943424 |
Device Name: | CUSH ISLAND DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
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 | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-15 |
Decision Date | 1994-10-03 |