FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
K Number: K904239
·
Decision Jun 21, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
13
Review Days
281
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Basic Information
- Device Name
- SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
- K Number
- K904239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Microbio-Medics, Inc.
- Date Received
- September 13, 1990
- Decision Date
- June 21, 1991
- 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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Other Clearances by Microbio-Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923353 | VENTILATION TUBES W/ HYDROGEL COATING | May 18, 1993 | Substantially Equivalent |
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | Nov 2, 1992 | Substantially Equivalent |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Oct 21, 1991 | Substantially Equivalent |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Apr 15, 1991 | Substantially Equivalent |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | May 4, 1990 | Substantially Equivalent |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Mar 20, 1990 | Substantially Equivalent |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Dec 26, 1989 | Substantially Equivalent |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | Dec 26, 1989 | Substantially Equivalent |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Dec 8, 1989 | Substantially Equivalent |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Apr 19, 1989 | Substantially Equivalent |