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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 K001251
Device Name SNIPER, MODEL OR-3872XX SERIES
Applicant
Nipro Medical Corp.
1445 Flat Greek Rd.
Athens,  TX 
Applicant Contact JACK FRAUTSCHI
Correspondent
Nipro Medical Corp.
1445 Flat Greek Rd.
Athens,  TX 
Correspondent Contact JACK FRAUTSCHI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/19/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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