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FDA 510(k) Application Details - K962713
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K962713
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.,
LOCKHEED AIR CENTER
MANCHESTER, NH 03103 US
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Contact
RONALD L COTNER
Other 510(k) Applications for this Contact
Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
07/12/1996
Decision Date
10/23/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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