The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Shave Prep Tray.
Device ID | K935739 |
510k Number | K935739 |
Device Name: | SHAVE PREP TRAY |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
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 | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-01 |
Decision Date | 1994-02-09 |