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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, natural
510(k) Number K982646
Device Name AILEE SUTURES AND AILEE NEEDLES
Applicant
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Applicant Contact SANJIV KUMAR
Correspondent
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Correspondent Contact SANJIV KUMAR
Regulation Number878.4830
Classification Product Code
GAL  
Subsequent Product Codes
GAM   GAN   GAO   GAP   GAR  
GAS   GAW   HMN  
Date Received07/29/1998
Decision Date 06/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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