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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryophthalmic
510(k) Number K790102
Device Name MODEL 556-01 CRYOEXTRACTOR
Applicant
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4170
Classification Product Code
HPS  
Date Received01/16/1979
Decision Date 02/12/1979
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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