The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for Dms-9000.
Device ID | K960836 |
510k Number | K960836 |
Device Name: | DMS-9000 |
Classification | Disinfectant, Medical Devices |
Applicant | O.R. SOLUTIONS, INC. 14014 SULLYFIELD CIRCLE SUITE A Chantilly, VA 22021 |
Contact | Mark Licata |
Correspondent | Mark Licata O.R. SOLUTIONS, INC. 14014 SULLYFIELD CIRCLE SUITE A Chantilly, VA 22021 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-29 |
Decision Date | 1996-09-12 |