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FDA 510(k) Application Details - K971089
Device Classification Name
Drape, Surgical
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510(K) Number
K971089
Device Name
Drape, Surgical
Applicant
OPPORTUNITY, INC.
1200 OLD SKOKIE RD.
HIGHLAND PARK, IL 60035 US
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Contact
JAMES S SANDERS
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Regulation Number
878.4370
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Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
09/16/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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