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

STERILE ORTHOPEDIC STOCKINETTE

K Number: K812904 · Decision Jan 18, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
8
Review Days
91

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Basic Information

Device Name
STERILE ORTHOPEDIC STOCKINETTE
K Number
K812904
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.5940
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Alba Health Care
Date Received
October 19, 1981
Decision Date
January 18, 1982
Product Code
LGF
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

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

Product Code Device Name
LGF Component, Cast

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Other Clearances by Alba Health Care

K Number Device Name
K864689 ALBA HEALTH CARE IODOFORM PACKING STRIP
K861154 ALBA HEALTH CARE PLAIN PACKING STRIP
K851918 INFANT PHOTOTHERAPY MASK
K850881 ALBA DRY BURN PAD
K850904 ALBA DRY BURN DRESSING
K850241 ALBA HEALTH CARE NON-ADHERING DRESSING
K803171 PROCEDURE & RECOVERY PATIENT SUIT