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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors, Ophthalmic
510(k) Number K770040
Device Name SCISSORS, STRABIMUS, 4 STRAIGHT
Applicant
J. Sklar Mfg. Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
J. Sklar Mfg. Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4350
Classification Product Code
HNF  
Date Received01/10/1977
Decision Date 01/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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