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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 K945342
Device Name MAG-1 SPECTACLE FRAME
Applicant
Criss Optical Mfg. Co., Inc.
3628 S. W. St.
P.O. Box 12267
Wichita,  KS  67217
Applicant Contact DIANE J LOVEALL
Correspondent
Criss Optical Mfg. Co., Inc.
3628 S. W. St.
P.O. Box 12267
Wichita,  KS  67217
Correspondent Contact DIANE J LOVEALL
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/01/1994
Decision Date 11/28/1994
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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