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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K945055
Device Name HARKEN ASSURE SELF-SEAL STERILIZATION POUCH
Applicant
Harken Products, Inc.
15709 Arrow Hwy., Suite 5
Irwindall,  CA  91706
Applicant Contact CHARLES R HARDER
Correspondent
Harken Products, Inc.
15709 Arrow Hwy., Suite 5
Irwindall,  CA  91706
Correspondent Contact CHARLES R HARDER
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/14/1994
Decision Date 12/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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