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FDA 510(k) Application Details - K983308
Device Classification Name
Spirometer, Therapeutic (Incentive)
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510(K) Number
K983308
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN, VA 23112 US
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Contact
MIGUEL A ARRIZON
Other 510(k) Applications for this Contact
Regulation Number
868.5690
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Classification Product Code
BWF
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More FDA Info for this Product Code
Date Received
09/21/1998
Decision Date
06/04/1999
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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