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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K903490
Device Name NORPLANT(R) TROCAR
Applicant
Wyeth-Ayerst Laboratories, Inc.
P.O. 8299
Philadelphia,  PA  19101
Applicant Contact JUSTIN R VICTORIA
Correspondent
Wyeth-Ayerst Laboratories, Inc.
P.O. 8299
Philadelphia,  PA  19101
Correspondent Contact JUSTIN R VICTORIA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/24/1990
Decision Date 11/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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