FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL LIGHT
K Number: K823360
·
Decision Dec 3, 1982
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
19
Review Days
28
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Basic Information
- Device Name
- SURGICAL LIGHT
- K Number
- K823360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Amsco Co.
- Date Received
- November 5, 1982
- Decision Date
- December 3, 1982
- 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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HM-LAMP II
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STRYKER KNIFELIGHT
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·General, Plastic Surgery
Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912471 | EAGLE 3000 SDS | Jun 26, 1992 | Substantially Equivalent |
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K811242 | DISPOSABLE STERILIZATION WRAP | May 21, 1981 | Substantially Equivalent |