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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dress, Surgical
510(k) Number K895235
Device Name VARIOUS DISPOSABLE SURGICAL GARMENTS
Applicant
Protect Corp. of Indiana, Inc.
3717 N. Rural
Indianapolis,  IN  46218
Applicant Contact RICHARD H GRAVES
Correspondent
Protect Corp. of Indiana, Inc.
3717 N. Rural
Indianapolis,  IN  46218
Correspondent Contact RICHARD H GRAVES
Regulation Number878.4040
Classification Product Code
FYE  
Date Received08/07/1989
Decision Date 09/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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