510(k) K891586
- Device
- ORAL AIRWAY
- Applicant
- DYNAREX CORP.
- 510(k) number
- K891586
- Product code
- CAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-11
- Date received
- 1989-03-20
- Regulation
- 868.5110
- Classification name
- Airway, Oropharyngeal, Anesthesiology
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Clearance type
- Traditional
- Third party reviewed
- No
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 |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | King Systems Corp. | 2004-04-14 |
| 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 |
Legacy Summary#
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FDA Review#
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