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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Electrical Dental Anesthesia
510(k) Number K873605
Device Name COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE
Applicant
Pain Prevention Laboratory, Inc.
3400 Dundee Rd.
Northbrook,  IL  60062
Applicant Contact JESS HALPERN
Correspondent
Pain Prevention Laboratory, Inc.
3400 Dundee Rd.
Northbrook,  IL  60062
Correspondent Contact JESS HALPERN
Classification Product Code
LWM  
Date Received09/04/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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