FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K Number: K992138
·
Decision Aug 9, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
29
Review Days
46
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Basic Information
- Device Name
- MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
- K Number
- K992138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedics, Inc.
- Date Received
- June 24, 1999
- Decision Date
- August 9, 1999
- Product Code
- ETA
- 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 |
|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Sep 1, 2005 | Substantially Equivalent |
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