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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Binder, Elastic
510(k) Number K792629
Device Name STERILIZATION PROCESS/T-BINDER
Applicant
Procter & Gamble Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Procter & Gamble Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5160
Classification Product Code
KMO  
Date Received12/19/1979
Decision Date 01/11/1980
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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