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

MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT

K Number: K823737 · Decision Jan 12, 1983
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
1
Review Days
30

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Basic Information

Device Name
MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT
K Number
K823737
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5780
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Gotfried Medical, Inc.
Date Received
December 13, 1982
Decision Date
January 12, 1983
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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