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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dryer, Film, Radiographic
510(k) Number K902531
Device Name EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
Applicant
G-C Intl. Corp.
7830 E.Redfield Rd. Suite 12
(Gc Tells Of Firm Closing)
Scottsdale,  AZ  85260
Applicant Contact WILLIAM R JACOBS
Correspondent
G-C Intl. Corp.
7830 E.Redfield Rd. Suite 12
(Gc Tells Of Firm Closing)
Scottsdale,  AZ  85260
Correspondent Contact WILLIAM R JACOBS
Regulation Number892.1900
Classification Product Code
EGW  
Date Received06/05/1990
Decision Date 07/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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