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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 K843197
Device Name VISITEC EYE SHIELD
Applicant
VISITEC CO.
2043 WHITFIELD PARK DR.
SARASOTA,  FL  33580
Applicant Contact Eugene H. Beckstein
Correspondent
VISITEC CO.
2043 WHITFIELD PARK DR.
SARASOTA,  FL  33580
Correspondent Contact Eugene H. Beckstein
Regulation Number878.4440
Classification Product Code
HMP  
Date Received08/14/1984
Decision Date 10/05/1984
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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