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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, synthetic, polyglycolic acid
510(k) Number K980610
Device Name DEXON RAPID (DEXON R)
Applicant
DAVIS & GECK, INC.
444 MC DONNELL BLVD.
HAZELWOOD,  MO  63042
Applicant Contact VANADA JOHNSON
Correspondent
DAVIS & GECK, INC.
444 MC DONNELL BLVD.
HAZELWOOD,  MO  63042
Correspondent Contact VANADA JOHNSON
Regulation Number878.4493
Classification Product Code
GAM  
Date Received02/17/1998
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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