FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS

K Number: K123820 · Decision Apr 2, 2013
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
1
Review Days
111

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Basic Information

Device Name
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
K Number
K123820
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5780
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Bossong Hosiery Mills, Inc.
Date Received
December 12, 2012
Decision Date
April 2, 2013
Product Code
DWL
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
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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