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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous irrigation
510(k) Number K873097
Device Name PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
Applicant
IPAX, INC.
2109 WEST AMHERST AVE.
ENGLEWOOD,  CO  80110
Applicant Contact PENNELL
Correspondent
IPAX, INC.
2109 WEST AMHERST AVE.
ENGLEWOOD,  CO  80110
Correspondent Contact PENNELL
Regulation Number878.4200
Classification Product Code
GBQ  
Date Received07/27/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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