FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL LIGHTING-CENTRA 450
K Number: K902864
·
Decision Sep 10, 1990
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
21
Review Days
73
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Basic Information
- Device Name
- SURGICAL LIGHTING-CENTRA 450
- K Number
- K902864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sds Dental, Inc.
- Date Received
- June 29, 1990
- Decision Date
- September 10, 1990
- 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 Sds Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990546 | DELSONIC 2000 | Nov 5, 1999 | Substantially Equivalent |
| K990545 | JETSONIC 2000 | Aug 11, 1999 | Substantially Equivalent |
| K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | Jan 22, 1997 | Substantially Equivalent |
| K902865 | BAUMER SURGICAL TABLE | Sep 10, 1990 | Substantially Equivalent |
| K863011 | DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II | Oct 10, 1986 | Substantially Equivalent |
| K863021 | CM-II, CM-I WATER UNIT | Oct 1, 1986 | Substantially Equivalent |
| K863016 | DENTATUS L SET | Oct 1, 1986 | Substantially Equivalent |
| K863007 | EUROFLEX F-IV, ISOFLEX III | Oct 1, 1986 | Substantially Equivalent |
| K863015 | ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT | Oct 1, 1986 | Substantially Equivalent |
| K863013 | ISOLAX PEDAL SET | Oct 1, 1986 | Substantially Equivalent |