FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KARLSON OZONE STERILIZER MODEL 100B
K Number: K873200
·
Decision Jan 27, 1989
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
25
Applicant Total
3
Review Days
533
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Basic Information
- Device Name
- KARLSON OZONE STERILIZER MODEL 100B
- K Number
- K873200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Life Enhancement Technologies, LLC
- Date Received
- August 13, 1987
- Decision Date
- January 27, 1989
- Product Code
- FLF
- 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 |
|---|---|---|---|
| FLF | Sterilizer, Ethylene-Oxide Gas | FDA class 2 | General Hospital |
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