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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 K872607
Device Name INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
Applicant
Randolph Engineering, Inc.
385 S. St.
Randolph,  MA  02368
Applicant Contact RICHARD WASZKIEWICZ
Correspondent
Randolph Engineering, Inc.
385 S. St.
Randolph,  MA  02368
Correspondent Contact RICHARD WASZKIEWICZ
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/06/1987
Decision Date 10/05/1987
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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