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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shell, Scleral
510(k) Number K855105
Device Name SIMMONS SHELL
Applicant
Mira, Inc.
87 Rumford Ave.
Waltham,  MA  02453
Applicant Contact MARK W FURLONG
Correspondent
Mira, Inc.
87 Rumford Ave.
Waltham,  MA  02453
Correspondent Contact MARK W FURLONG
Regulation Number886.3800
Classification Product Code
HQT  
Date Received12/23/1985
Decision Date 03/31/1986
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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