FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCHEM INDICATOR TAPE
K Number: K080307
·
Decision May 1, 2008
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
1
Review Days
86
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Basic Information
- Device Name
- PROCHEM INDICATOR TAPE
- K Number
- K080307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Raven Laboratories
- Date Received
- February 5, 2008
- Decision Date
- May 1, 2008
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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