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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K820269
Device Name RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
Applicant
CIVCO Medical Instruments Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
CIVCO Medical Instruments Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
DWO  
Date Received02/02/1982
Decision Date 03/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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