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

FREEDOM, MODEL 4660

K Number: K001023 · Decision Sep 22, 2000
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
2
Review Days
176

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
FREEDOM, MODEL 4660
K Number
K001023
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Johnson & Johnson Consumer Companies, Inc.
Date Received
March 30, 2000
Decision Date
September 22, 2000
Product Code
SEJ
Advisory Committee
Unknown
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
SEJ Wound Dressings Containing Topical Analgesics

Similar 510(k) Clearances

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

View all

Other Clearances by Johnson & Johnson Consumer Companies, Inc.

K Number Device Name
K062602 BAND-AID(R) BRAND LIQUID BANDAGE