FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

STERILE ORTHOPEDIC STOCKINETTE

K Number: K780547 · Decision Apr 10, 1978
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
7
Applicant Total
8
Review Days
5

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Basic Information

Device Name
STERILE ORTHOPEDIC STOCKINETTE
K Number
K780547
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.3475
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Alba-Waldensian, Inc.
Date Received
April 5, 1978
Decision Date
April 10, 1978
Product Code
ILG
Advisory Committee
Physical Medicine
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
ILG Stocking, Elastic

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Other Clearances by Alba-Waldensian, Inc.

K Number Device Name
K020592 ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K961405 ALBA HEALTH PAS WRAP SYSTEM
K852091 ALBA DRY BURN PAD
K792357 STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
K781964 COMPRESSION DEVICES, LIMB
K780570 TUBULAR DRESSING RETAINER
K771913 HEEL/ELBOW PROTECTOR