FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAZLYTE(TM)
K Number: K905119
·
Decision Dec 22, 1994
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
25
Applicant Total
3
Review Days
1499
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Basic Information
- Device Name
- PLAZLYTE(TM)
- K Number
- K905119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abtox, Inc.
- Date Received
- November 14, 1990
- Decision Date
- December 22, 1994
- 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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