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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K941448
Device Name RETRACTOR
Applicant
Technovations
646 E. Apple Tree Dr.
Sandy,  UT  84070
Applicant Contact DREW D WEAVER
Correspondent
Technovations
646 E. Apple Tree Dr.
Sandy,  UT  84070
Correspondent Contact DREW D WEAVER
Regulation Number878.4800
Classification Product Code
GAD  
Date Received03/24/1994
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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