FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K Number: K903650
·
Decision Sep 14, 1990
Classifications
1
FEI Numbers
387
Registration Numbers
387
Same Product Code
75
Applicant Total
40
Review Days
32
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Basic Information
- Device Name
- OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
- K Number
- K903650
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Date Received
- August 13, 1990
- Decision Date
- September 14, 1990
- Product Code
- HWE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Micro-Aire Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | Nov 26, 1990 | Substantially Equivalent |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | Sep 14, 1990 | Substantially Equivalent |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Sep 14, 1990 | Substantially Equivalent |
| K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL | Sep 13, 1990 | Substantially Equivalent |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Jul 13, 1990 | Substantially Equivalent |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | Jun 20, 1990 | Substantially Equivalent |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | Jun 20, 1990 | Substantially Equivalent |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | Feb 13, 1990 | Substantially Equivalent |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | Feb 2, 1990 | Substantially Equivalent |
| K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | Nov 22, 1989 | Substantially Equivalent |