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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Latex Patient Examination Glove
510(k) Number K942086
Device Name PATIENT EXAMINATION GLOVE
Applicant
Qrp, Inc.
P.O. Box 28802
Tuscon,  AZ  85726
Applicant Contact ALBERT M HALL
Correspondent
Qrp, Inc.
P.O. Box 28802
Tuscon,  AZ  85726
Correspondent Contact ALBERT M HALL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/02/1994
Decision Date 07/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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