COATED TUNGSTEN EYESHIELD
FDA 510(k) clearance K945515 · decided 1995-06-19
Clearance details
- K-number
- K945515
- Device name
- COATED TUNGSTEN EYESHIELD
- Applicant
- Medtec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-09
- Decision date
- 1995-06-19
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- IWS
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orange City, IA, 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 |
|---|---|---|
| ROYAL MARSDEN GOLD GRAIN GUN (K940119) | Best Industries | 1994-12-30 |
| TUNGSTEN EYESHIELD (K943011) | Medtec, Inc. | 1994-12-23 |
| MED-GENESIS PATIENT LASER EYE SHIELD (K934459) | Med-Genesis, Inc. | 1994-02-22 |
| NUCLEAR ASSOCIATES GLASSERS (K934362) | Victoreen, Inc. | 1993-11-12 |
| RADIOLOGICAL PROTECTIVE EYE SHIELD (K920540) | Burkhart Roentgen Intl., Inc. | 1992-05-28 |
Recalls involving this device
No recalls on record reference this clearance.