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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 K864290
Device Name RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
Applicant
KEELER INSTRUMENTS, INC.
456 pkwy.
broomall,  PA  19008
Applicant Contact van arsdale
Correspondent
KEELER INSTRUMENTS, INC.
456 pkwy.
broomall,  PA  19008
Correspondent Contact van arsdale
Regulation Number886.4350
Classification Product Code
HNN  
Date Received10/31/1986
Decision Date 12/15/1986
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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