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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K934506
Device Name DYNABITE HYSTEROSCOPIC FORCEPS
Applicant
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Applicant Contact GEORGE A LYNA
Correspondent
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Correspondent Contact GEORGE A LYNA
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/14/1993
Decision Date 03/22/1994
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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