FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

GAUZE SPONGES ABSORBENT GAUZE ROLLS

K Number: K910623 · Decision Apr 1, 1991
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
6
Review Days
47

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Basic Information

Device Name
GAUZE SPONGES ABSORBENT GAUZE ROLLS
K Number
K910623
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Liaoning-Usa Corp.
Date Received
February 13, 1991
Decision Date
April 1, 1991
Product Code
EFQ
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
EFQ Gauze/Sponge, Internal

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K Number Device Name
K911921 DISPOSABLE ISOLATION GOWN
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K902625 CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT
K892781 ANTELOPE BRAND PATIENT EXAMINATION GLOVES
K892774 PATIENT EXAMINATION GLOVES