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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K953678
Device Name STERIMED STERIZATION WRAPPER (NON-STERILE)
Applicant
Customed, Inc.
Calle Industrial Final, Hvy.
#3, Km. 45.0
Fajardo,  PR  00648
Applicant Contact FELIXX B SANTOS
Correspondent
Customed, Inc.
Calle Industrial Final, Hvy.
#3, Km. 45.0
Fajardo,  PR  00648
Correspondent Contact FELIXX B SANTOS
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/07/1995
Decision Date 10/02/1995
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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