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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K893964
Device Name SPECTRASTIM TM 1000
Applicant
Therapeutic Technologies, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
Therapeutic Technologies, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/02/1989
Decision Date 10/06/1989
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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