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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K844840
Device Name DESERET INTRODUCER SET
Applicant
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Applicant Contact CLEARY
Correspondent
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Correspondent Contact CLEARY
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/12/1984
Decision Date 05/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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