FDA 510(k)
Substantially Equivalent
🇺🇸 United States
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K Number: K925588
·
Decision Dec 3, 1993
Classifications
0
FEI Numbers
8
Registration Numbers
8
Same Product Code
80
Applicant Total
16
Review Days
393
Basic Information
- Device Name
- NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
- K Number
- K925588
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NORTH AMERICAN STERILIZATION & PACKAGING CO.
- Date Received
- November 5, 1992
- Decision Date
- December 3, 1993
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
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