510(k) K941325
- Device
- Water Irrigator, W1 200
- Applicant
- STRONG MEDICAL, INC.
- 510(k) number
- K941325
- Product code
- KHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-09
- Date received
- 1994-03-18
- Regulation
- 874.1800
- Classification name
- Stimulator, Caloric-Air
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL MCAFEE
- Address
- St. X, Industrial Area Heraklion GR
FDA Registration Numbers#
- 3005581270
- 9710051
- 1836161
- 3011310592
- 9710334
- 8010573
- 9612197
- 3005527904
- 8030607
- 3034880867
- 8010257
- 3011522961
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | 1995-06-28 |
| K946108 | EAR-A-GATOR | Life-Tech Intl., Inc. | 1995-06-13 |
| K931608 | NCA-200 | Ics Medical Corp. | 1993-06-22 |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1993-05-05 |
| K881630 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1988-06-21 |
| K822179 | FRENZEL EYEGLASSES & RELATED ITEMS | Kelleher Corp. | 1982-09-21 |