The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Circumcision Tray.
| Device ID | K935697 |
| 510k Number | K935697 |
| Device Name: | CIRCUMCISION TRAY |
| Classification | Clamp, Circumcision |
| 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 | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-05-02 |