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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 K934249
Device Name TRACTION PRODUCTIONS SPECTACLE FRAMES
Applicant
Traction Productions, USA
10752 Bustleton Ave.
Philadelphia,  PA  19116
Applicant Contact BERNARD GUSSMAN
Correspondent
Traction Productions, USA
10752 Bustleton Ave.
Philadelphia,  PA  19116
Correspondent Contact BERNARD GUSSMAN
Regulation Number886.5842
Classification Product Code
HQZ  
Subsequent Product Code
HQY  
Date Received08/27/1993
Decision Date 11/02/1993
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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