510(k) K852345
- Device
- Sea-long Neckseal & Hood
- Applicant
- SAFETY SEA SYSTEMS, INC.
- 510(k) number
- K852345
- Product code
- BYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-20
- Date received
- 1985-05-31
- Regulation
- 868.5700
- Classification name
- Tent, Oxygen
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE WYMER
- Address
- 207 Kah-Lac Ln. Rt.2 Ponchatoula LA US 70454 70454
FDA Registration Numbers#
- 3031369651
- 3010131137
- 1924066
- 1836161
- 3003862188
- 3030152374
- 3013345545
- 3006192512
- 3011137372
- 3013976593
- 8043316
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BYL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935126 | NASCOR IGLOO | Nascor Pty. , Ltd. | 1994-10-18 |
| K905627 | NASCOR OXYDOME | Nascor Pty. , Ltd. | 1991-06-03 |
| K896608 | SPAG PAK | Viratek, Inc. | 1990-04-09 |
| K895866 | DIRD INGANT O2 (BIO 2 HOOD) | Bird Products Corp. | 1989-10-27 |
| K893713 | NOVA OXYGEN TENT | Nova Health Systems, Inc. | 1989-08-21 |
| K893714 | KEYSTONE OXYGEN TENT | Keystone Veterinary Supplies, Inc. | 1989-08-21 |
| K882396 | AEROSOL DELIVERY HOOD | Viratek, Inc. | 1988-08-01 |
| K851666 | MEDI-COMP NEONATAL OXYGEN HOOD | Medicomp, Inc. | 1985-08-06 |
| K820640 | HOO2D SEAT-INFANT | Dhd Medical Products Div. Diemolding Corp. | 1982-03-26 |
| K802653 | MEDIUM SIZE OXYGEN HOOD #1547 | Ann Arbor Plastics, Inc. | 1980-11-24 |