510(k) K973128
- Device
- OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K973128
- Product code
- FOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-18
- Date received
- 1997-08-21
- Regulation
- 868.5700
- Classification name
- Hood, Oxygen, Infant
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUBHASH R PATEL
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 3017103765
- 9710391
- 3037040712
- 3013595329
- 1718873
- 3011529314
- 3018762668
- 1722070
- 1000280680
- 3013976593
- 3008381089
- 3009039068
Source Documents#
Other 510(k) Records For Product Code FOG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962182 | BURLEW INFANT HOOD | Promedic, Inc. | 1996-07-15 |
| K955482 | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | Advantage Medical Services, Inc. | 1996-01-30 |
| K830781 | ENDO-GUARD | Jayco Pharmaceuticals | 1983-03-31 |
| K792144 | DISPOSA-HOOD | Utah Medical Products, Inc. | 1979-12-05 |
| K791861 | OXYGEN HOODS | Ann Arbor Plastics, Inc. | 1979-10-04 |
| K790860 | RT-HOOD | Plastics Supplies & Products | 1979-05-29 |
| K780220 | HOOD, INFANT OXYGEN | Shiley, Inc. | 1978-04-10 |
| K770754 | DUODENOSCOPE, MOLEL TX-6 | American Cystocope Makers, Inc. | 1977-04-28 |
Legacy Summary#
summary
FDA Review#
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