FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

SUPRASORB A +AG

K Number: K071442 · Decision May 1, 2008
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
2
Review Days
344

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Basic Information

Device Name
SUPRASORB A +AG
K Number
K071442
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Specialty Fibres and Materials, Ltd.
Date Received
May 23, 2007
Decision Date
May 1, 2008
Product Code
FRO
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
FRO Dressing, Wound, Drug

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K Number Device Name
K173844 Titan Ag 200