The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Dental Tray.
Device ID | K941349 |
510k Number | K941349 |
Device Name: | DENTAL TRAY |
Classification | Unit, Operative Dental |
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 | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-21 |
Decision Date | 1994-07-26 |