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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K990567
Device Name GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
Applicant
Global Healthcare, Inc.
130 Brantley Rd.
Atlanta,  GA  30350
Applicant Contact ALAM AHMED
Correspondent
Global Healthcare, Inc.
130 Brantley Rd.
Atlanta,  GA  30350
Correspondent Contact ALAM AHMED
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/23/1999
Decision Date 04/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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