ROLLED NECK W/PLUG
FDA 510(k) clearance K841411 · decided 1984-04-18
Clearance details
- K-number
- K841411
- Device name
- ROLLED NECK W/PLUG
- Applicant
- Warne Surgical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-05
- Decision date
- 1984-04-18
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- BTC
- Device class
- 1
- Regulation number
- 868.5320
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PeDIA (K181424) | Pedia, LLC | 2018-09-25 |
| REBREATHER BAGS (K940220) | Zefon Medical Products | 1994-05-27 |
| PRECISION MED PRODUCTS, LTD. BREATHING BAGS (K932496) | Precision Med Products, Ltd. | 1993-07-16 |
| BREATHING BAGS (K932581) | Med-Plastics Intl., Inc. | 1993-07-16 |
| BREATHING BAGS (K932584) | Merit Medical Systems, Inc. | 1993-07-16 |
| BREATHING BAGS (K932191) | Life Shield Healthcare Products, Inc. | 1993-07-02 |
| ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (K894906) | Med-Tek Corp. | 1989-09-18 |
| KING SYSTEMS, BREATHING BAG (K880680) | King Systems Corp. | 1988-03-03 |
| VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (K864822) | Surgidyne, Inc. | 1987-01-15 |
| ROLLED NECK W/TAP (K841412) | Warne Surgical Products, Ltd. | 1984-04-18 |
| COUPLING/VALVE (K830399) | Khi, Inc. | 1983-03-10 |
| ARTEC TWIST VALVE (K830056) | Artec Environmental Monitoring Division | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.