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

ACTIVATOR II

K Number: K973506 · Decision Jan 27, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
31
Applicant Total
1
Review Days
133

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Basic Information

Device Name
ACTIVATOR II
K Number
K973506
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Activator Methods, Inc.
Date Received
September 16, 1997
Decision Date
January 27, 1998
Product Code
LXM
Advisory Committee
Unknown
Review Advisory Committee
PM
Third Party
N

Classifications

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

Product Code Device Name
LXM Manipulator, Plunger-Like Joint

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