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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 K960738
Device Name STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)
Applicant
ENGINEERED CUSTOM MFG., INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657
Applicant Contact ALLAN FRIEZE
Correspondent
ENGINEERED CUSTOM MFG., INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657
Correspondent Contact Tania Lupu
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/23/1996
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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