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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K011905
Device Name SNIPER ELITE MODEL-OR-E3872XX SERIES
Applicant
MAXXIM MEDICAL
1445 FLAT CREEK RD.
ATHENS,  TX  75751
Applicant Contact GAIL DOHERTY
Correspondent
MAXXIM MEDICAL
1445 FLAT CREEK RD.
ATHENS,  TX  75751
Correspondent Contact GAIL DOHERTY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/19/2001
Decision Date 08/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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