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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K952083
Device Name TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
Applicant
Clover Medical Equipment Services, Inc.
172 Holtz Dr.
Buffalo,  NY  14225
Applicant Contact RONALD LUICH
Correspondent
Clover Medical Equipment Services, Inc.
172 Holtz Dr.
Buffalo,  NY  14225
Correspondent Contact RONALD LUICH
Regulation Number868.5880
Classification Product Code
CAD  
Date Received05/03/1995
Decision Date 10/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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