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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K843041
Device Name HESLIN DISPOS. TUBING SET
Applicant
INNOVATIVE SURGICAL PRODUCTS INC.
1201 EAST WAKEHAM
SANTA ANA,  CA  92705
Applicant Contact DUANE MASON
Correspondent
INNOVATIVE SURGICAL PRODUCTS INC.
1201 EAST WAKEHAM
SANTA ANA,  CA  92705
Correspondent Contact DUANE MASON
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/02/1984
Decision Date 11/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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