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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sterilizer, Dry Heat
510(k) Number K881371
Device Name COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
Applicant
Cox Sterile Products, Inc.
5115 Mckinney Ave., Suite C
Dallas,  TX  75205
Applicant Contact COX, D.D.S.
Correspondent
Cox Sterile Products, Inc.
5115 Mckinney Ave., Suite C
Dallas,  TX  75205
Correspondent Contact COX, D.D.S.
Regulation Number880.6870
Classification Product Code
KMH  
Date Received04/01/1988
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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