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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Maxwell Spot, Ac-Powered
510(k) Number K831829
Device Name KARICKHOFF FLYING CORPUSCLE VIEWER
Applicant
Surgidev Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Surgidev Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.1435
Classification Product Code
HIX  
Date Received06/07/1983
Decision Date 10/19/1983
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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