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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 K910515
Device Name FREEDOM MARK III SURGICAL HELMET SYSTEM
Applicant
Stackhouse Assoc.
2059 Atlanta Ave.
Riverside,  CA  92507
Applicant Contact GREEN, JR.
Correspondent
Stackhouse Assoc.
2059 Atlanta Ave.
Riverside,  CA  92507
Correspondent Contact GREEN, JR.
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/05/1991
Decision Date 05/06/1991
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
Recalls CDRH Recalls
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