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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K881618
Device Name ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact JACQUELYN A BUSH
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact JACQUELYN A BUSH
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/15/1988
Decision Date 05/09/1988
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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