FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO-AIRE STERNUM SAW 4800
K Number: K894301
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
15
Review Days
41
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Basic Information
- Device Name
- MICRO-AIRE STERNUM SAW 4800
- K Number
- K894301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Micro Surgical Instruments Corp.
- Date Received
- June 23, 1989
- Decision Date
- August 3, 1989
- Product Code
- KFK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KFK | Saw, Pneumatically Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFK), ordered by most recent decision date.
#157 EXAM LIGHT
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FDA Class 1
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STERNUM SAW
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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|---|---|---|---|
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K932492 | IMPLANTOLOGY MODULE, MODEL 2175 | Oct 5, 1993 | Substantially Equivalent |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Aug 2, 1993 | Substantially Equivalent |
| 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 |