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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K170635
Device Name Chameleon PTA Balloon Catheter
Applicant
AV Medical Technologies Ltd
21 B Habarzel Street
Tel-Aviv,  IL 6971029
Applicant Contact Limor Sandach
Correspondent
Dohmen Life Sciences Services, LLC
11925 W I-70 Frontage Rd.
North Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact Eliza Malo
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
KRA  
Date Received03/02/2017
Decision Date 03/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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