FDA 510(k) Application Details - K960955

Device Classification Name Catheter, Irrigation

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510(K) Number K960955
Device Name Catheter, Irrigation
Applicant BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK, IL 60085 US
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Contact INGRID M HOOS
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Regulation Number 878.4200

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Classification Product Code GBX
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Date Received 03/11/1996
Decision Date 05/22/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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