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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K882168
Device Name EXTERNAL PACEMAKER 2000 (EP2000)
Applicant
Unomed, Inc.
13180 N. Cleveland Ave.
Ft. Myers,  FL  33903
Applicant Contact DENNIS R TRAILER
Correspondent
Unomed, Inc.
13180 N. Cleveland Ave.
Ft. Myers,  FL  33903
Correspondent Contact DENNIS R TRAILER
Regulation Number870.5550
Classification Product Code
DRO  
Date Received05/24/1988
Decision Date 08/19/1988
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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