510(k) K033186
- Device
- KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
- Applicant
- KING SYSTEMS CORP.
- 510(k) number
- K033186
- Product code
- CAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-14
- Date received
- 2003-10-01
- Regulation
- 868.5110
- Classification name
- Airway, Oropharyngeal, Anesthesiology
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM MCGRAIL
- Address
- 15011 Herriman Blvd. Noblesville IN US 46060 46060
FDA Registration Numbers#
- 3002224346
- 1250045
- 3013557562
- 3006552462
- 9680661
- 3023272766
- 3010583519
- 3006061749
- 3006984712
- 3021282544
- 3016734145
- 3006783791
- 3010400865
- 3015745029
- 3015142701
- 3004488394
- 3000126629
- 3010396739
- 3032912822
- 3009747810
- 2183416
- 3015173212
- 3005587132
- 3006787036
- 3012287892
- 2518422
- 3012508471
- 3008733158
- 9681848
- 1417592
- 3012777736
- 3012445994
- 3009171251
- 3003481016
- 3003851906
- 3006430057
- 3030017177
- 1319447
- 3027605742
- 3007494890
- 9610861
- 3017171849
- 3014437893
- 3030078769
- 3009771213
- 3009307931
- 3014656749
- 3013530901
- 1824226
- 3042617724
- 8021995
- 2529489
- 3013530405
- 2027062
- 3015142721
- 3015495690
- 3008676146
- 3032916566
- 3003622639
- 3010621964
- 3023339256
- 8043817
- 2025816
- 3010580321
- 3007681502
- 3003924186
- 3020798191
- 3003674698
- 3007997596
- 3010957755
- 2518436
- 3013528571
- 3001313714
- 3021010418
- 3015139770
- 3018762668
- 1832562
- 3010439239
- 3016763307
- 9610691
Source Documents#
Other 510(k) Records For Product Code CAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130304 | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | 2014-05-30 |
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | King Systems Corp. | 2004-05-04 |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | 2003-01-09 |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mallinckrodt Medical | 1997-03-28 |
| K960240 | RUSCH OPTOSAFE | Rusch Intl. | 1996-04-19 |
| K950613 | KEISEI | Keisei (Usa) Co., Ltd. | 1996-02-14 |
| K953400 | GUEDEL AIRWAY | Mallinckrodt Medical | 1995-10-24 |
| K933760 | STB GUEDEL AIRWAY | Save-T-Breath Distributors C.C. | 1994-03-23 |
| K936134 | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | 1994-01-28 |
| K922748 | GUEDEL AIRWAY | Oem Medical Div. | 1992-07-10 |
| K913680 | BERMAN INTUBATING/PHARYNGEAL AIRWAY | Chain Plastics Operations, Inc. | 1991-10-10 |
| K904834 | INTAVENT LARYNGEAL MASK | Intavent Intl. S.A. | 1991-07-26 |
| K891926 | KISS OF LIFE | Anthony Don Michael, M.D. | 1989-08-21 |
| K892123 | GOETTINGER EMERGENCY RESUSCITATION TUBE | Plastic Parts Corp. | 1989-07-14 |
| K891586 | ORAL AIRWAY | Dynarex Corp. | 1989-05-11 |
Legacy Summary#
summary
FDA Review#
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