NASOPORE EAR, MODELS ND04, ND05
FDA 510(k) clearance K062540 · decided 2006-10-18
Clearance details
- K-number
- K062540
- Device name
- NASOPORE EAR, MODELS ND04, ND05
- Applicant
- Polyganics B.V.,
- Decision
- Substantially Equivalent
- Date received
- 2006-08-30
- Decision date
- 2006-10-18
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KCN
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Groningen, NL
- 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 |
|---|---|---|
| INVOTEC EAR TAMPON (WICK) W/STRING (K973578) | Invotec International, Inc. | 1997-11-06 |
| ULTRACELL EAR WICK (K920357) | Ultracell Medical Technologies, Inc. | 1993-02-01 |
| POPE OTO-WICK, STERILE & NON-STERILE (K791059) | Xomed, Inc. | 1979-07-17 |
Recalls involving this device
No recalls on record reference this clearance.