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FDA 510(k) Application Details - K971988
Device Classification Name
Table, Operating-Room, Ac-Powered
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510(K) Number
K971988
Device Name
Table, Operating-Room, Ac-Powered
Applicant
ALLEN MEDICAL SYSTEMS, INC.
15627 NEO PKWY.
CLEVELAND, OH 44128 US
Other 510(k) Applications for this Company
Contact
SUZANNE KAY RATZLOFF
Other 510(k) Applications for this Contact
Regulation Number
878.4960
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Classification Product Code
FQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/1997
Decision Date
07/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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