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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
510(k) Number K844836
Device Name HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
Applicant
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Applicant Contact JEFFREY GREEN
Correspondent
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Correspondent Contact JEFFREY GREEN
Regulation Number866.3220
Classification Product Code
GWD  
Date Received12/12/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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