SHILEY LOW PRESSURE THIN-CUFFED TRACH.
FDA 510(k) clearance K792222 · decided 1979-12-18
Clearance details
- K-number
- K792222
- Device name
- SHILEY LOW PRESSURE THIN-CUFFED TRACH.
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-05
- Decision date
- 1979-12-18
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- EQN
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| OP-CON SURG. INSTRUMENT #7 (K834172) | Imm Enterprises , Ltd. | 1984-03-06 |
| LARYNGOSCOPE ATTACHMENT PH2000 (K831255) | Eder Instrument Co, Inc. | 1983-09-12 |
| COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (K830888) | National Medical Technology | 1983-04-27 |
| LARYNGOSCOPES RIGID (K822525) | Kelleher Corp. | 1982-09-09 |
| NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (K821707) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA LIGHT SOURCE UNIT SL-4 (K821708) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA LIGHT SOURCE UNIT SL-5 (K821709) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (K821706) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA NX-150F LIGHT SOURCE UNIT (K821710) | Kelleher Corp. | 1982-06-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |