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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pad, eye
510(k) Number K940333
Device Name EYE PAD
Applicant
CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY,  MO  64127
Applicant Contact HOWARD GERSON
Correspondent
CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY,  MO  64127
Correspondent Contact HOWARD GERSON
Regulation Number878.4440
Classification Product Code
HMP  
Date Received01/25/1994
Decision Date 03/07/1994
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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