FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PDS PLATES
K Number: K092590
·
Decision Feb 17, 2010
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
14
Applicant Total
204
Review Days
177
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Basic Information
- Device Name
- PDS PLATES
- K Number
- K092590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, Inc.
- Date Received
- August 24, 2009
- Decision Date
- February 17, 2010
- Product Code
- NHB
- 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 |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHB), ordered by most recent decision date.
SeptAlign
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SeptAlign
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Spirair Nasal Septal Strap
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·Ear, Nose, Throat
PosiSep EAR Fragmentable Ear Dressing
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LATERA Absorbable Nasal Implant System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PuraSinus
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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