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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 K860528
Device Name THE KEYMED FIBERSCOPE STERILIZATION CASE
Applicant
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Applicant Contact ROGER GRAY
Correspondent
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Correspondent Contact ROGER GRAY
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/11/1986
Decision Date 07/15/1986
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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