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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K872233
Device Name INJECT-EASE
Applicant
Palco Laboratories, Inc.
1595 Soquel Dr.
Santa Cruz,  CA  95065
Applicant Contact LEVIN, M.D.
Correspondent
Palco Laboratories, Inc.
1595 Soquel Dr.
Santa Cruz,  CA  95065
Correspondent Contact LEVIN, M.D.
Regulation Number880.6920
Classification Product Code
KZH  
Date Received06/10/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
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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