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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K904136
Device Name SUTURE TENSION ADJUSTMENT REEL
Applicant
Surgical Systems, Inc.
Kendall Professional Bldg.
9150 Southwest 87 Ave.
Miami,  FL  33176
Applicant Contact COHEN, MD
Correspondent
Surgical Systems, Inc.
Kendall Professional Bldg.
9150 Southwest 87 Ave.
Miami,  FL  33176
Correspondent Contact COHEN, MD
Regulation Number878.4930
Classification Product Code
KGS  
Date Received09/06/1990
Decision Date 10/02/1990
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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