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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K202071
Device Name SURGIPHOR Wound Irrigation System
Applicant
Orthophor, LLC
125 S. 9th St.
Sheridan Bldg., Suite 1001
Philadelphia,  PA  19107
Applicant Contact Alan Miller
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Elizabeth O’Keeffe
Regulation Number880.5475
Classification Product Code
FQH  
Date Received07/27/2020
Decision Date 10/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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