FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANTOLOGY MODULE, MODEL 2175
K Number: K932492
·
Decision Oct 5, 1993
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
15
Review Days
134
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Basic Information
- Device Name
- IMPLANTOLOGY MODULE, MODEL 2175
- K Number
- K932492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Surgical Instruments Corp.
- Date Received
- May 24, 1993
- Decision Date
- October 5, 1993
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Micro Surgical Instruments Corp.
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|---|---|---|---|
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| K914998 | MICROAIRE(R) FACIAL BONE PLATING SYSTEM | Jun 2, 1992 | Substantially Equivalent |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | Feb 5, 1992 | Substantially Equivalent |
| K914346 | DRILL MODULES MODELS 2116/2117 | Nov 27, 1991 | Substantially Equivalent |
| K913369 | MICRO-AIRE MODEL 2060 | Nov 1, 1991 | Substantially Equivalent |
| K913266 | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS | Oct 21, 1991 | Substantially Equivalent |
| K910175 | FIXATION DEVICES AND BONE PLATE | Jun 21, 1991 | Substantially Equivalent for Some Indications |
| K905383 | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | Jun 18, 1991 | Substantially Equivalent |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Jan 22, 1991 | Substantially Equivalent for Some Indications |