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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K910067
Device Name PTI STERNAL CLOSURE WIRE SUTURE
Applicant
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact WRIGHT
Correspondent
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact WRIGHT
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received01/09/1991
Decision Date 05/06/1991
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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