FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE EQUALIZER
K Number: K801328
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
57
Review Days
6
Basic Information
- Device Name
- THE EQUALIZER
- K Number
- K801328
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- THE ANSPACH EFFORT, INC.
- Date Received
- June 3, 1980
- Decision Date
- June 9, 1980
- Product Code
- MDM
- 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 |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
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| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | Jan 26, 2007 | Substantially Equivalent |
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| K050628 | ANSPACH COUPLER | Apr 7, 2005 | Substantially Equivalent |
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