FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURASIL I AND DURASIL II
K Number: K973730
·
Decision Dec 24, 1997
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
14
Review Days
85
Basic Information
- Device Name
- DURASIL I AND DURASIL II
- K Number
- K973730
- 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
- HANSON MEDICAL, INC.
- Date Received
- September 30, 1997
- Decision Date
- December 24, 1997
- Product Code
- MIB
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | FDA class 2 | Ear, Nose, Throat |
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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 |
| K041690 | MONARCH NASAL IMPLANT | Feb 11, 2005 | Substantially Equivalent |
| K040307 | HANSON SCAR ADE | Aug 12, 2004 | Substantially Equivalent |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | Apr 21, 2003 | Substantially Equivalent |
| K030808 | HANSON MEDICAL CALF IMPLANT | Apr 21, 2003 | Substantially Equivalent |
| K973729 | POWERFLEX PEC IMPLANT | Dec 24, 1997 | Substantially Equivalent |
| K973728 | SILICONE CARVING BLOCK | Nov 13, 1997 | Substantially Equivalent |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Nov 13, 1997 | Substantially Equivalent |