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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Material, Impression
510(k) Number K955465
Device Name DEGUPRINT
Applicant
Degussa Corp.
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact HOLGER MEINICKE
Correspondent
Degussa Corp.
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact HOLGER MEINICKE
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/30/1995
Decision Date 12/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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