FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLY PISTON
K Number: K945108
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
71
Applicant Total
14
Review Days
35
Basic Information
- Device Name
- POLY PISTON
- K Number
- K945108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3450
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICROMED DEVELOPMENT CORP.
- Date Received
- October 18, 1994
- Decision Date
- November 22, 1994
- Product Code
- ETB
- 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by MICROMED DEVELOPMENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K945105 | POLY/PLATINUM WIRE PISTON | May 14, 1996 | Substantially Equivalent |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Jan 20, 1995 | Substantially Equivalent |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Dec 27, 1994 | Substantially Equivalent |
| K945107 | POLY-WIRE PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | Nov 22, 1994 | Substantially Equivalent |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Sep 16, 1994 | Substantially Equivalent |
| K943847 | BOBBIN STYLE VENTURI VENT TUBE | Sep 2, 1994 | Substantially Equivalent |
| K943849 | GROMMENT STYLE VENTURI TUBE | Sep 2, 1994 | Substantially Equivalent |