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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K871202
Device Name FLASHPAK CONTAINER SYSTEM
Applicant
Performance Instruments Corp.
4 Mulliken Way
Newburyport,  MA  01950
Applicant Contact RUSSELL P HOLMES
Correspondent
Performance Instruments Corp.
4 Mulliken Way
Newburyport,  MA  01950
Correspondent Contact RUSSELL P HOLMES
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/25/1987
Decision Date 05/29/1987
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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