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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K981073
Device Name MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
Applicant
Medcom Laundry Service, Inc.
517 N. Link Ln., Unit D
Fort Collins,  CO  80524
Applicant Contact GARY VANDRIEL
Correspondent
Medcom Laundry Service, Inc.
517 N. Link Ln., Unit D
Fort Collins,  CO  80524
Correspondent Contact GARY VANDRIEL
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
KKX  
Date Received03/24/1998
Decision Date 05/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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