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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K893118
Device Name AOR-SULLIVAN PROTECTIVE OVERGLOVE
Applicant
Aor-Sullivan
10064 Mesa Ridge Ct. Suite
212
San Diego,  CA  92121
Applicant Contact MIKE PETERSEN
Correspondent
Aor-Sullivan
10064 Mesa Ridge Ct. Suite
212
San Diego,  CA  92121
Correspondent Contact MIKE PETERSEN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received04/25/1989
Decision Date 06/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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