FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
K Number: K950822
·
Decision Mar 22, 1995
Classifications
0
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
1
Review Days
28
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Basic Information
- Device Name
- SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
- K Number
- K950822
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solopak Laboratories, Inc.
- Date Received
- February 22, 1995
- Decision Date
- March 22, 1995
- Product Code
- LDH
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
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