FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

STERI-SWAB

K Number: K912731 · Decision Oct 2, 1991
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
1
Review Days
104

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Basic Information

Device Name
STERI-SWAB
K Number
K912731
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Westlock Investments (Usa), Inc.
Date Received
June 20, 1991
Decision Date
October 2, 1991
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
LKB Pad, Alcohol, Device Disinfectant

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