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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K970873
Device Name ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
Applicant
AMERICAN MEDICAL DEVICES, INC.
1100 NORTHSIDE DR.
ATLANTA,  GA  30318
Applicant Contact FRANK J TIGHE
Correspondent
AMERICAN MEDICAL DEVICES, INC.
1100 NORTHSIDE DR.
ATLANTA,  GA  30318
Correspondent Contact FRANK J TIGHE
Regulation Number886.4350
Classification Product Code
HMX  
Date Received03/10/1997
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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