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510(k) Data Aggregation
K Number
K981073Device Name
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
Manufacturer
Date Cleared
1998-05-15
(52 days)
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MEDCOM LAUNDRY SERVICE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material.
To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination.
To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc.
Device Description
Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable
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