The following data is part of a premarket notification filed by Well Lead Medical Instruments with the FDA for Well Lead Endotracheal Tube.
Device ID | K042683 |
510k Number | K042683 |
Device Name: | WELL LEAD ENDOTRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-29 |
Decision Date | 2005-02-18 |
Summary: | summary |