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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 K904037
Device Name PUMUCKL AND/OR DIETERLE
Applicant
Pumuckl
8407 Bandera # 133
San Antonio,  TX  78250
Applicant Contact SCHIEFERLE
Correspondent
Pumuckl
8407 Bandera # 133
San Antonio,  TX  78250
Correspondent Contact SCHIEFERLE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received09/04/1990
Decision Date 09/24/1990
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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