FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110
K Number: K771865
·
Decision Nov 28, 1977
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
21
Review Days
56
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Basic Information
- Device Name
- DAYSTAR SURG. LIGHT 9100 & ORBITER 9110
- K Number
- K771865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Castle Co.
- Date Received
- October 3, 1977
- Decision Date
- November 28, 1977
- Product Code
- FSY
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Castle Co.
| K Number | Device Name | ||
|---|---|---|---|
| K870975 | MODIFIED CASTLE POWERCLAVE | Apr 17, 1987 | Substantially Equivalent |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | Mar 5, 1986 | Substantially Equivalent |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Jan 14, 1985 | Substantially Equivalent |
| K834048 | BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO | Apr 4, 1984 | Substantially Equivalent |
| K833074 | CASTLE TEC-TEST S.M.A.R.T. PACK | Nov 7, 1983 | Substantially Equivalent |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Jun 15, 1983 | Substantially Equivalent |
| K792660 | 1500 EO EXHAUST HOOD | Jan 29, 1980 | Substantially Equivalent |
| K792649 | UNISPORE-BIOLOGICAL INDICATORS | Jan 29, 1980 | Substantially Equivalent |
| K790677 | EO EVACUATING SYSTEM I | May 7, 1979 | Substantially Equivalent |
| K781887 | 9100 DAYSTAR AND 9110 ORBITER PACKAGE | Dec 12, 1978 | Substantially Equivalent |