FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CASTLE WASHER/DISINFECTOR, MODEL 7550
K Number: K911087
·
Decision Aug 9, 1993
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
882
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Basic Information
- Device Name
- CASTLE WASHER/DISINFECTOR, MODEL 7550
- K Number
- K911087
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Mdt Biologic Co.
- Date Received
- March 11, 1991
- Decision Date
- August 9, 1993
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| 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 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Jun 11, 1991 | Substantially Equivalent |