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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dress, Surgical
510(k) Number K910920
Device Name PROTEKT GLOVES
Applicant
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Applicant Contact THOMAS L CRAIG
Correspondent
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Correspondent Contact THOMAS L CRAIG
Regulation Number878.4040
Classification Product Code
FYE  
Date Received03/05/1991
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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