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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K851407
Device Name SURGICAL TOWELS
Applicant
Diack
7755 Narrow Gauge Rd.
Beulah,  MI  49617
Applicant Contact ROBERT F SMITH
Correspondent
Diack
7755 Narrow Gauge Rd.
Beulah,  MI  49617
Correspondent Contact ROBERT F SMITH
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/09/1985
Decision Date 06/07/1985
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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