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 |