FDA 510(k) Application Details - K961263

Device Classification Name Pump, Infusion

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510(K) Number K961263
Device Name Pump, Infusion
Applicant PATIENT SOLUTIONS, INC.
13220 EVENING CREEK DR. SO.,
SUITE 114
SAN DIEGO, CA 92128 US
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Contact TOM KANE
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 04/02/1996
Decision Date 08/23/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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