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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 K844329
Device Name SURFLEX F
Applicant
G-C Intl. Corp.
7830 E.Redfield Rd. Suite 12
(Gc Tells Of Firm Closing)
Scottsdale,  AZ  85260
Applicant Contact DONALD A MCKENZIE
Correspondent
G-C Intl. Corp.
7830 E.Redfield Rd. Suite 12
(Gc Tells Of Firm Closing)
Scottsdale,  AZ  85260
Correspondent Contact DONALD A MCKENZIE
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/07/1984
Decision Date 12/03/1984
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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