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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K901896
Device Name ENDOMETRIAL SAMPLER
Applicant
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Applicant Contact KIRWAN, JR.
Correspondent
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Correspondent Contact KIRWAN, JR.
Regulation Number872.5410
Classification Product Code
EJF  
Date Received04/25/1990
Decision Date 08/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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