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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K932538
Device Name CABOT MEDICAL IRRIGATION FLUID WARMER SETS
Applicant
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Applicant Contact TODD POLK
Correspondent
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Correspondent Contact TODD POLK
Regulation Number890.5950
Classification Product Code
LHC  
Date Received05/26/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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