FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINOR SURGICAL LIGHT MODEL 180
K Number: K841360
·
Decision Apr 24, 1984
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
28
Applicant Total
36
Review Days
22
Basic Information
- Device Name
- MINOR SURGICAL LIGHT MODEL 180
- K Number
- K841360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN STERILIZER CO.
- Date Received
- April 2, 1984
- Decision Date
- April 24, 1984
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by AMERICAN STERILIZER CO.
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|---|---|---|---|
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| K922485 | CHEMDI-VHP CHEMICAL INDICATOR | Sep 29, 1993 | Substantially Equivalent |
| K930493 | QUANTUM 3080 SURGICAL TABLE | Jun 22, 1993 | Substantially Equivalent |
| K905816 | ORTHOVISION TABLE | Mar 6, 1991 | Substantially Equivalent |
| K896674 | AMSCO QUANTUM LIGHT | Jan 3, 1990 | Substantially Equivalent |
| K895164 | EAGLE DS | Nov 17, 1989 | Substantially Equivalent |
| K882660 | GENERAL SURGICAL TABLE AND ACCESSORIES | Jul 25, 1988 | Substantially Equivalent |
| K880198 | GEMINI SURGICAL LIGHT | Feb 10, 1988 | Substantially Equivalent |
| K864846 | RADIOGRAPHIC - LEG SECTION | Dec 24, 1986 | Substantially Equivalent |