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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 K953829
Device Name SAFE-T-SEAL
Applicant
Gs Medical Packaging, Inc.
6890 Pacific Cir.
Mississauga, Ontario,  CA L5T 1N8
Applicant Contact JOHN SHERLOCK
Correspondent
Gs Medical Packaging, Inc.
6890 Pacific Cir.
Mississauga, Ontario,  CA L5T 1N8
Correspondent Contact JOHN SHERLOCK
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/16/1995
Decision Date 11/09/1995
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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