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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, polyamide
510(k) Number K981582
Device Name SURGILON, DERMALON, & OPHTHALON
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 Number878.5020
Classification Product Code
GAR  
Date Received05/04/1998
Decision Date 07/13/1998
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
Recalls CDRH Recalls
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