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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transilluminator, Battery-Powered
510(k) Number K901309
Device Name SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
Applicant
SYLVAN CORP.
P.O. BOX 362,
612 CEDAR STREET
IRWIN,  PA  15642
Applicant Contact JAMES G FEDORKA
Correspondent
SYLVAN CORP.
P.O. BOX 362,
612 CEDAR STREET
IRWIN,  PA  15642
Correspondent Contact JAMES G FEDORKA
Regulation Number886.1945
Classification Product Code
HJN  
Date Received03/20/1990
Decision Date 05/24/1990
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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