The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Lt-d Disposable Oropharyngeal Airway, Models Klt 203, Klt 204 And Klt 205.
Device ID | K033186 |
510k Number | K033186 |
Device Name: | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 |
Classification | Airway, Oropharyngeal, Anesthesiology |
Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
Contact | Tom Mcgrail |
Correspondent | Tom Mcgrail KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
Product Code | CAE |
CFR Regulation Number | 868.5110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-01 |
Decision Date | 2004-04-14 |
Summary: | summary |