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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K924837
Device Name DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET
Applicant
Associated Ent., Inc.
623 Charlie Hicks Rd.
Jonesborough,  TN  37659
Applicant Contact LEACH
Correspondent
Associated Ent., Inc.
623 Charlie Hicks Rd.
Jonesborough,  TN  37659
Correspondent Contact LEACH
Classification Product Code
LDQ
Date Received09/25/1992
Decision Date 10/12/1993
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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