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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K921632
Device Name INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK
Applicant
Lawrence Technologies, Inc.
3450 Brumbaugh Blvd.
Dayton,  OH  45406
Applicant Contact LAWRENCE J RICHARDS
Correspondent
Lawrence Technologies, Inc.
3450 Brumbaugh Blvd.
Dayton,  OH  45406
Correspondent Contact LAWRENCE J RICHARDS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received04/06/1992
Decision Date 12/23/1992
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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