The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Hyperinflation Bag System, Model 83-900-0149.
Device ID | K001714 |
510k Number | K001714 |
Device Name: | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 |
Classification | Resuscitator, Manual, Non Self-inflating |
Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
Contact | Ron Rupenski |
Correspondent | Ron Rupenski MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
Product Code | NHK |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-05 |
Decision Date | 2000-11-03 |