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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 K931662
Device Name LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
Applicant
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Applicant Contact ROBERT C MACE
Correspondent
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Correspondent Contact ROBERT C MACE
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Codes
DQX   DRE  
Date Received04/05/1993
Decision Date 08/31/1993
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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