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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Moldable, Supportive, Skin Protective
510(k) Number K940132
Device Name PODIATRIC MATERIAL
Applicant
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Applicant Contact LAURENCE COLIN
Correspondent
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Correspondent Contact LAURENCE COLIN
Regulation Number890.3475
Classification Product Code
MNE  
Date Received01/03/1994
Decision Date 09/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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