FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE STEAM STERILIZERS
K Number: K895848
·
Decision Dec 11, 1989
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
28
Review Days
69
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Basic Information
- Device Name
- PRESSURE STEAM STERILIZERS
- K Number
- K895848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Scientific Device Laboratory, Inc.
- Date Received
- October 3, 1989
- Decision Date
- December 11, 1989
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Scientific Device Laboratory, Inc.
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|---|---|---|---|
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| K911059 | TURBIDOMETRIC STANDARD | Jun 10, 1991 | Substantially Equivalent |
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| K890718 | GRAM STAIN CONTROL SLIDE | Mar 16, 1989 | Substantially Equivalent |
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| K884011 | SNAP N' STAIN IRON STAIN | Oct 6, 1988 | Substantially Equivalent |
| K883052 | METHENO-STAIN KIT | Aug 30, 1988 | Substantially Equivalent |
| K881598 | SDL TRICHROME STAIN | May 4, 1988 | Substantially Equivalent |
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