The following data is part of a premarket notification filed by Dj Medical, Inc. with the FDA for Dj Medical Pneumatic Tourniquet.
Device ID | K945167 |
510k Number | K945167 |
Device Name: | DJ MEDICAL PNEUMATIC TOURNIQUET |
Classification | Tourniquet, Pneumatic |
Applicant | DJ MEDICAL, INC. 11221 FANWOOD COURT Richmond, VA 23233 |
Contact | Stephen J Leibovic |
Correspondent | Stephen J Leibovic DJ MEDICAL, INC. 11221 FANWOOD COURT Richmond, VA 23233 |
Product Code | KCY |
CFR Regulation Number | 878.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-22 |
Decision Date | 1995-02-13 |