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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 K141412
Device Name STERILUCENT SELF-SEAL STERILIZATION POUCH
Applicant
Gs Medical Packaging, Inc.
1400 Marshall St., NE
Minneapolis,  MN  55413
Applicant Contact PETER KALKBRENNER
Correspondent
Gs Medical Packaging, Inc.
1400 Marshall St., NE
Minneapolis,  MN  55413
Correspondent Contact PETER KALKBRENNER
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/29/2014
Decision Date 12/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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