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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 K910975
Device Name TEKDYNE MICRO RETRACTOR
Applicant
Tekdyne
Main And Juniper St.S
3rd Floor
Quakertown,  PA  18951
Applicant Contact ALAN J BITNER
Correspondent
Tekdyne
Main And Juniper St.S
3rd Floor
Quakertown,  PA  18951
Correspondent Contact ALAN J BITNER
Regulation Number878.4800
Classification Product Code
GAD  
Date Received03/07/1991
Decision Date 04/01/1991
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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