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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 K951214
Device Name STERILE EQUIPMENT COVER
Applicant
Gulfstream Medical
212 W. Cayaga Dr.
Athens,  TX  75751
Applicant Contact ALEX WITHERS
Correspondent
Gulfstream Medical
212 W. Cayaga Dr.
Athens,  TX  75751
Correspondent Contact ALEX WITHERS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/17/1995
Decision Date 05/16/1995
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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