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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K970161
Device Name HEDGES CORNEAL WETTING PAK
Applicant
Hedges Cwp, Inc.
105 Spring House Ct.
Cherry Hill,  NJ  08002
Applicant Contact DAVID JASPAN
Correspondent
Hedges Cwp, Inc.
105 Spring House Ct.
Cherry Hill,  NJ  08002
Correspondent Contact DAVID JASPAN
Regulation Number886.4360
Classification Product Code
KYG  
Subsequent Product Code
FPA  
Date Received01/14/1997
Decision Date 03/25/1997
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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