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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K920649
Device Name COMPASEP
Applicant
Wilde-USA, Inc.
1819 So. May St.
Unit 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
Wilde-USA, Inc.
1819 So. May St.
Unit 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number880.6250
Classification Product Code
FMC  
Date Received02/12/1992
Decision Date 07/23/1992
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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