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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Surgical, Gynecological
510(k) Number K901897
Device Name ZEPPELIN FORCEPS
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 Number884.4530
Classification Product Code
HCZ  
Date Received04/25/1990
Decision Date 06/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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