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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Preamplifier, Ac-Powered, Ophthalmic
510(k) Number K924277
Device Name DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
Applicant
Chalgren Enterprises, Inc.
8021 Carmel St.
Suite B
Gilroy,  CA  95020
Applicant Contact RICHARD KAISER
Correspondent
Chalgren Enterprises, Inc.
8021 Carmel St.
Suite B
Gilroy,  CA  95020
Correspondent Contact RICHARD KAISER
Regulation Number886.1640
Classification Product Code
HLT  
Subsequent Product Code
HLW  
Date Received08/25/1992
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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