FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POREX NOSTRIL RETAINERS
K Number: K981374
·
Decision Jul 2, 1998
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
19
Review Days
77
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Basic Information
- Device Name
- POREX NOSTRIL RETAINERS
- K Number
- K981374
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Porex Surgical, Inc.
- Date Received
- April 16, 1998
- Decision Date
- July 2, 1998
- Product Code
- LYA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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| K091120 | MEDPOR CONTAIN IMPLANT | Mar 19, 2010 | Substantially Equivalent |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Feb 3, 2009 | Substantially Equivalent |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Aug 8, 2007 | Substantially Equivalent |
| K052297 | POREX ELECTROSURGERY NEEDLE | Mar 28, 2006 | Substantially Equivalent |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Jul 16, 2004 | Substantially Equivalent |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | Jun 30, 2004 | Substantially Equivalent |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Aug 5, 2002 | Substantially Equivalent |