FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PIV SYSTEM
K Number: K981032
·
Decision Sep 2, 1998
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
4
Review Days
167
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Basic Information
- Device Name
- PIV SYSTEM
- K Number
- K981032
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Solutions, Inc.
- Date Received
- March 19, 1998
- Decision Date
- September 2, 1998
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
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