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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 K881372
Device Name ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
Applicant
Endicott & Beaman, Inc.
22 Pecan Valley Dr.
New City,  NY  10956
Applicant Contact NATALIE TRAGER
Correspondent
Endicott & Beaman, Inc.
22 Pecan Valley Dr.
New City,  NY  10956
Correspondent Contact NATALIE TRAGER
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/01/1988
Decision Date 04/08/1988
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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