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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 K973440
Device Name REXAM FRACTURE RESISTANT POUCH
Applicant
Rexam Medical Packaging, Inc.
1919 S. Butterfield Rd.
Mundelein,  IL  60060
Applicant Contact ANDREA HAFERKAMP
Correspondent
Rexam Medical Packaging, Inc.
1919 S. Butterfield Rd.
Mundelein,  IL  60060
Correspondent Contact ANDREA HAFERKAMP
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/10/1997
Decision Date 10/20/1997
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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