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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K191295
Device Name Percutaneous Introducer Needle
Applicant
Progressive Medical, Inc.
997 Horan Dr.
fenton,  MO  63026
Applicant Contact roland d. sullivan
Correspondent
Mullis & Associates, Inc.
367 Pleasant Valley Rd., P.O. Box 39
good hope,  GA  30641
Correspondent Contact david w. mullis
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/14/2019
Decision Date 08/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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