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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K921833
Device Name ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
Applicant
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact MELISSA WALKER
Correspondent
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact MELISSA WALKER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/16/1992
Decision Date 09/21/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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