FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONARCH NASAL IMPLANT
K Number: K041690
·
Decision Feb 11, 2005
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
14
Review Days
234
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Basic Information
- Device Name
- MONARCH NASAL IMPLANT
- K Number
- K041690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hanson Medical, Inc.
- Date Received
- June 22, 2004
- Decision Date
- February 11, 2005
- Product Code
- FZE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Hanson Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | Aug 5, 2014 | Substantially Equivalent |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | Jun 30, 2010 | Substantially Equivalent |
| K071018 | MONARCH NASAL IMPLANT | May 25, 2007 | Substantially Equivalent |
| K040307 | HANSON SCAR ADE | Aug 12, 2004 | Substantially Equivalent |
| K030808 | HANSON MEDICAL CALF IMPLANT | Apr 21, 2003 | Substantially Equivalent |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | Apr 21, 2003 | Substantially Equivalent |
| K973730 | DURASIL I AND DURASIL II | Dec 24, 1997 | Substantially Equivalent |
| K973729 | POWERFLEX PEC IMPLANT | Dec 24, 1997 | Substantially Equivalent |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Nov 13, 1997 | Substantially Equivalent |
| K973728 | SILICONE CARVING BLOCK | Nov 13, 1997 | Substantially Equivalent |