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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K933584
Device Name SACRED CRANE TDP
Applicant
Telstar Innovations, Inc.
3455 St. Rd.
Franklin #9
Bensalem,  PA  19020
Applicant Contact SIMON TIAN
Correspondent
Telstar Innovations, Inc.
3455 St. Rd.
Franklin #9
Bensalem,  PA  19020
Correspondent Contact SIMON TIAN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/26/1993
Decision Date 01/27/1994
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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