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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Loupe, Binocular, Low Power
510(k) Number K863983
Device Name EXETER OPERATING LOUPE
Applicant
Exeter Instruments, Inc.
148 Batchelder Rd.
P.O. Box 1498
Seabrook,  NH  03874
Applicant Contact DAVID BASTABLE
Correspondent
Exeter Instruments, Inc.
148 Batchelder Rd.
P.O. Box 1498
Seabrook,  NH  03874
Correspondent Contact DAVID BASTABLE
Regulation Number886.5120
Classification Product Code
HJH  
Date Received10/14/1986
Decision Date 11/10/1986
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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