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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K043383
Device Name N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
Applicant
Physion, Inc.
51 John F. Kennedy Pkwy.
Short Hills,  NJ  07078 -5006
Applicant Contact ERIC J NEMETH, ESQ.
Correspondent
Physion, Inc.
51 John F. Kennedy Pkwy.
Short Hills,  NJ  07078 -5006
Correspondent Contact ERIC J NEMETH, ESQ.
Regulation Number876.1500
Classification Product Code
FBK  
Date Received12/09/2004
Decision Date 10/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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