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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K780126
Device Name DILATOR, VESSEL & INTRODUCER, SHEATH
Applicant
Argon Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Argon Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1310
Classification Product Code
DRE  
Date Received01/24/1978
Decision Date 03/02/1978
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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