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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, Synthetic, Polyester
510(k) Number K953128
Device Name SUTURE CORD
Applicant
Phoenix Biomedical Corp.
2495 General Armstead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Applicant Contact HORACE J WILMER
Correspondent
Phoenix Biomedical Corp.
2495 General Armstead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Correspondent Contact HORACE J WILMER
Regulation Number878.5000
Classification Product Code
GAS  
Date Received07/06/1995
Decision Date 02/09/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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