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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Specula Accessories
510(k) Number K891589
Device Name 3MM DISPOSABLE SPECULA
Applicant
Semantodontics, Inc.
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Applicant Contact DANIEL F ENRIQUEZ
Correspondent
Semantodontics, Inc.
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Correspondent Contact DANIEL F ENRIQUEZ
Regulation Number878.1800
Classification Product Code
FXG  
Date Received03/20/1989
Decision Date 04/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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