FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HMD-2000 BATTERY-POWERED MINI-DRILL, THE
K Number: K780645
·
Decision May 3, 1978
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
8
Review Days
16
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Basic Information
- Device Name
- HMD-2000 BATTERY-POWERED MINI-DRILL, THE
- K Number
- K780645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medishield, Inc.
- Date Received
- April 17, 1978
- Decision Date
- May 3, 1978
- Product Code
- KIJ
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Medishield, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K781103 | SPECTRASCAN | Sep 27, 1978 | Substantially Equivalent |
| K780646 | AIR-PWOERED COLDRILL | Apr 28, 1978 | Substantially Equivalent |
| K780202 | MONOMER EVACUATION SYSTEM | Feb 21, 1978 | Substantially Equivalent |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | Jan 26, 1977 | Substantially Equivalent |
| K761020 | ANKLE (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K760668 | SELECTATEC SYSTEM | Sep 27, 1976 | Substantially Equivalent |