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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Environmental Control, Powered
510(k) Number K940223
Device Name LEARN MODE WATERPROOF PENDANT PANIC BUTTON
Applicant
Interactive Technologies, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Interactive Technologies, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number890.3725
Classification Product Code
IQA  
Date Received01/18/1994
Decision Date 04/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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