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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K850049
Device Name KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA
Applicant
Xtal Corp.
17 Hillside Dr.
Malverne,  PA  19355
Applicant Contact ALAN P SCHWARTZ
Correspondent
Xtal Corp.
17 Hillside Dr.
Malverne,  PA  19355
Correspondent Contact ALAN P SCHWARTZ
Regulation Number886.4350
Classification Product Code
HNN  
Date Received01/08/1985
Decision Date 03/06/1985
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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