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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K945577
Device Name GUARDIAN II GLOVE
Applicant
Guardian Group, Inc.
7770 Regents Rd., #539
San Diego,  CA  92122
Applicant Contact RON MELTON
Correspondent
Guardian Group, Inc.
7770 Regents Rd., #539
San Diego,  CA  92122
Correspondent Contact RON MELTON
Regulation Number880.6250
Classification Product Code
LZC  
Date Received11/14/1994
Decision Date 12/29/1994
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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