The following data is part of a premarket notification filed by Ohio Medical Corporation with the FDA for Moblvac W.c..
Device ID | K081185 |
510k Number | K081185 |
Device Name: | MOBLVAC W.C. |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | OHIO MEDICAL CORPORATION 1111 LAKESIDE DR. Gurnee, IL 60031 |
Contact | David Platt |
Correspondent | David Platt OHIO MEDICAL CORPORATION 1111 LAKESIDE DR. Gurnee, IL 60031 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-25 |
Decision Date | 2008-05-02 |