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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, ROUTE 25
MOULTONBORO,  NH  03254
Applicant Contact GEORGE A LYNA
Correspondent
PORTLYN CORP.
RFD #1 BOX 451, ROUTE 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
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