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FDA 510(k) Application Details - K945302
Device Classification Name
Accessory, Surgical Apparel
More FDA Info for this Device
510(K) Number
K945302
Device Name
Accessory, Surgical Apparel
Applicant
SLOAN CORP.
11033 W. MAPLE RD.
OMAHA, NE 68164 US
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Contact
STEWART SLOAN
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
LYU
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More FDA Info for this Product Code
Date Received
08/30/1994
Decision Date
03/19/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K945302
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