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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K021606
Device Name EN-SNARE ENDOVASCULAR SNARE AND CATHETER
Applicant
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number870.5150
Classification Product Code
MMX  
Date Received05/16/2002
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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