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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K932132
Device Name EYSOTEK
Applicant
Isotech Corp.
376 Wels Rd.
P.O. Box 9139
Wethersfield,  CT  06109
Applicant Contact RONALD E VLIET
Correspondent
Isotech Corp.
376 Wels Rd.
P.O. Box 9139
Wethersfield,  CT  06109
Correspondent Contact RONALD E VLIET
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/03/1993
Decision Date 04/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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