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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Battery-Powered
510(k) Number K882618
Device Name JEDMED/POLACK KERATOSCOPE HS/SL
Applicant
Gamut Ent.
2121 Fountain Dr. Suite N
Snellville,  GA  30078 -2900
Applicant Contact BOB HEWLETT
Correspondent
Gamut Ent.
2121 Fountain Dr. Suite N
Snellville,  GA  30078 -2900
Correspondent Contact BOB HEWLETT
Regulation Number886.1350
Classification Product Code
HLR  
Date Received06/24/1988
Decision Date 07/13/1988
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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