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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Anti-Snoring
510(k) Number K954128
Device Name SNOREMASTER
Applicant
D.D.S., Inc.
2181 St. Andrews Rd.
Half Moon Bay,  CA  94019
Applicant Contact VIRGINIA PERRY
Correspondent
D.D.S., Inc.
2181 St. Andrews Rd.
Half Moon Bay,  CA  94019
Correspondent Contact VIRGINIA PERRY
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/01/1995
Decision Date 10/02/1995
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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