510(k) K832476
- Device
- SILICONE SOFT-PAK EPISTAXIS CATHETER
- Applicant
- AXIOM MEDICAL, INC.
- 510(k) number
- K832476
- Product code
- ENW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-03
- Date received
- 1983-07-26
- Regulation
- 874.4175
- Classification name
- Catheter, Nasopharyngeal
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008808560
- 3003915875
- 3010166880
- 2025182
- 3005273623
- 3012448339
- 3003477135
- 1054811
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ENW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | American V. Mueller | 1985-07-22 |
Legacy Summary#
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FDA Review#
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