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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 K921571
Device Name 1ST IMPRESSION
Applicant
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Applicant Contact PAUL R DEMPSEY
Correspondent
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Correspondent Contact PAUL R DEMPSEY
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/02/1992
Decision Date 09/10/1993
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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