FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS
K Number: K873476
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
14
Review Days
11
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Basic Information
- Device Name
- MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS
- K Number
- K873476
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mcghan Medical Corp.
- Date Received
- August 31, 1987
- Decision Date
- September 11, 1987
- Product Code
- GEY
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Mcghan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Sep 11, 1987 | Substantially Equivalent |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | Mar 31, 1987 | Substantially Equivalent |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | Jul 23, 1986 | Substantially Equivalent |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | Dec 24, 1985 | Substantially Equivalent |
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT | Sep 18, 1985 | Substantially Equivalent |
| K843704 | MCGHAN TISSUE EXPANDER | Oct 31, 1984 | Substantially Equivalent |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Nov 22, 1978 | Substantially Equivalent |
| K781700 | IONOTPHORETIC APPLICATOR | Nov 3, 1978 | Substantially Equivalent |