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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 K780778
Device Name RTV SILICONE HAND KNEADABLE PUTTY
Applicant
Crown Delta Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Crown Delta Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/11/1978
Decision Date 05/31/1978
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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