The following data is part of a premarket notification filed by Tiger Medical Products Ltd with the FDA for Tiger Endotracheal Tubes (various Models And Sizes).
Device ID | K041311 |
510k Number | K041311 |
Device Name: | TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | TIGER MEDICAL PRODUCTS LTD 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
Contact | Jay Mansour |
Correspondent | Jay Mansour TIGER MEDICAL PRODUCTS LTD 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-17 |
Decision Date | 2005-03-18 |
Summary: | summary |