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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K913696
Device Name GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE
Applicant
Vertex Technical Group, Inc.
C/O Medical Marketing Consult
3 Bethesda Metro Ctr, Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE T DAVIS
Correspondent
Vertex Technical Group, Inc.
C/O Medical Marketing Consult
3 Bethesda Metro Ctr, Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE T DAVIS
Classification Product Code
LDQ
Date Received08/19/1991
Decision Date 02/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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