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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Battery-Powered
510(k) Number K881001
Device Name MENTOR WET-FIELD*II COAGULATOR
Applicant
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061 -1672
Applicant Contact MARK TOMA
Correspondent
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061 -1672
Correspondent Contact MARK TOMA
Regulation Number886.4100
Classification Product Code
HQQ  
Date Received03/09/1988
Decision Date 05/13/1988
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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