Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K921716
Device Name DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
Applicant
AMERICAN SURGICAL INSTRUMENTS CORP.
430 COMMERCE DRIVE, SUITE 50E
DELRAY BEACH,  FL  33445
Applicant Contact DORSEY, III
Correspondent
AMERICAN SURGICAL INSTRUMENTS CORP.
430 COMMERCE DRIVE, SUITE 50E
DELRAY BEACH,  FL  33445
Correspondent Contact DORSEY, III
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/09/1992
Decision Date 11/08/1993
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
-
-