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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K002849
Device Name PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Applicant Contact VIKKI M HOFFMAN
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/13/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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