FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
STERETS INJECTION SWAB
K Number: K852235
·
Decision Jun 7, 1985
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- STERETS INJECTION SWAB
- K Number
- K852235
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Ellis Pharmaceutical Consulting, Inc.
- Date Received
- May 22, 1985
- Decision Date
- June 7, 1985
- Product Code
- LKB
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
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