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

DISPOSABLE UNDERPADS

K Number: K811232 · Decision May 21, 1981
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
1
Review Days
17

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Basic Information

Device Name
DISPOSABLE UNDERPADS
K Number
K811232
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6060
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Burina
Date Received
May 4, 1981
Decision Date
May 21, 1981
Product Code
KME
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
KME Bedding, Disposable, Medical

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