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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Battery-Powered
510(k) Number K910088
Device Name SCITECH BI-MANUAL ADAPTER CLIPS
Applicant
Scitech Industries Partnership
28 Somerset Dr.
Woodcliff Lake,  NJ  07675
Applicant Contact JOHN D DUGAN
Correspondent
Scitech Industries Partnership
28 Somerset Dr.
Woodcliff Lake,  NJ  07675
Correspondent Contact JOHN D DUGAN
Regulation Number886.4100
Classification Product Code
HQQ  
Date Received01/09/1991
Decision Date 04/08/1991
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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