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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K844465
Device Name PMS DRAPE PACK
Applicant
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/19/1984
Decision Date 12/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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