FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
K Number: K910942
·
Decision Jun 11, 1991
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
19
Applicant Total
8
Review Days
97
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Basic Information
- Device Name
- AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
- K Number
- K910942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mdt Biologic Co.
- Date Received
- March 6, 1991
- Decision Date
- June 11, 1991
- Product Code
- FSS
- 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 |
|---|---|---|---|
| FSS | Light, Surgical, Floor Standing | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Mdt Biologic Co.
| K Number | Device Name | ||
|---|---|---|---|
| K954736 | ACCESS (POWERCLAVE) | Aug 15, 1996 | Substantially Equivalent |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Jan 17, 1996 | Substantially Equivalent |
| K943654 | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS | Aug 2, 1995 | Substantially Equivalent |
| K911087 | CASTLE WASHER/DISINFECTOR, MODEL 7550 | Aug 9, 1993 | Substantially Equivalent |
| K910777 | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER | Mar 27, 1992 | Substantially Equivalent |
| K910778 | STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) | Oct 28, 1991 | Substantially Equivalent |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Sep 6, 1991 | Substantially Equivalent |