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

AMERICAN ALCOHOL PREP PAD STERILE MEDIUM

K Number: K870718 · Decision May 7, 1987
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
19
Review Days
76

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Basic Information

Device Name
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K Number
K870718
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Span-America Medical Systems, Inc.
Date Received
February 20, 1987
Decision Date
May 7, 1987
Product Code
LKB
Advisory Committee
Unknown
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
LKB Pad, Alcohol, Device Disinfectant

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K961159 POWERED LOW AIR LOSS MATTRESS SYSTEM
K960620 PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960189 GEL-T CUSHION
K954766 PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K953503 PRESSUREGUARD IV
K954117 CUSTOMCARE SEATING SYSTEM
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