FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CLEAR (TM) LICE EGG REMOVER SYSTEM

K Number: K981147 · Decision Jun 9, 1998
Classifications
1
FEI Numbers
47
Registration Numbers
48
Same Product Code
10
Applicant Total
2
Review Days
71

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Basic Information

Device Name
CLEAR (TM) LICE EGG REMOVER SYSTEM
K Number
K981147
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.5960
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Care Technologies, Inc.
Date Received
March 30, 1998
Decision Date
June 9, 1998
Product Code
LJL
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
LJL Detectors And Removers, Lice, (Including Combs)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LJL), ordered by most recent decision date.

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Other Clearances by Care Technologies, Inc.

K Number Device Name
K981037 CLEAR (TM) SPECIAL NIT COMB