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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trap, Sterile Specimen
510(k) Number K925412
Device Name ELECTROMEDICS TISSUE TRAP/ #TT280
Applicant
ELECTROMEDICS, INC.
7337 SOUTH REVERE PKWY.
ENGLEWOOD,  CO  80112
Applicant Contact HAROLD W BRYAN
Correspondent
ELECTROMEDICS, INC.
7337 SOUTH REVERE PKWY.
ENGLEWOOD,  CO  80112
Correspondent Contact HAROLD W BRYAN
Regulation Number880.6740
Classification Product Code
BYZ  
Date Received10/26/1992
Decision Date 02/05/1993
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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