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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 K940807
Device Name SEE-THRU SELF SEALING STERILIZATION POUCH
Applicant
Asep-Pro, Inc.
26 Ironbark Way
Irvine,  CA  92715
Applicant Contact STEVEN B LEHAT
Correspondent
Asep-Pro, Inc.
26 Ironbark Way
Irvine,  CA  92715
Correspondent Contact STEVEN B LEHAT
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/22/1994
Decision Date 11/18/1994
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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