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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 K891213
Device Name SURGICAL INSTRUMENT POUCH #M102
Applicant
Pro-Safe Professional Linens, Inc.
304 W. Main St.
Grand Junction,  CO  81501
Applicant Contact SCOTT KAFKA
Correspondent
Pro-Safe Professional Linens, Inc.
304 W. Main St.
Grand Junction,  CO  81501
Correspondent Contact SCOTT KAFKA
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/07/1989
Decision Date 04/14/1989
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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