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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hand, Calculus Removal
510(k) Number K952363
Device Name OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
Applicant
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact CAHTERINE GOBLE
Correspondent
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact CAHTERINE GOBLE
Regulation Number872.4565
Classification Product Code
ELA  
Date Received05/01/1995
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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