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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K912252
Device Name INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
Applicant
FIBEROPTIC MEDICAL PRODUCTS, INC.
4000 BELL ATLANTIC TOWER
1717 ARCH STREET
PHILADELPHIA,  PA  19103
Applicant Contact JOHN B REISS
Correspondent
FIBEROPTIC MEDICAL PRODUCTS, INC.
4000 BELL ATLANTIC TOWER
1717 ARCH STREET
PHILADELPHIA,  PA  19103
Correspondent Contact JOHN B REISS
Regulation Number878.4580
Classification Product Code
FST  
Date Received05/21/1991
Decision Date 06/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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