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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K922186
FOIA Releasable 510(k) K922186
Device Name HEM-O-LOK -- MODIFICATION
Applicant
LINVATEC CORP.
P.O. BOX 12600 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact GLENN M MATTEI
Correspondent
LINVATEC CORP.
P.O. BOX 12600 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact GLENN M MATTEI
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/27/1992
Decision Date 08/06/1992
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
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