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 Speculum, Vaginal, Nonmetal
510(k) Number K880586
Device Name AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2
Applicant
C.I.S.A. Import Export C/O Larson and Taylor
9 E. 41st St.
New York,  NY  10017
Applicant Contact VICTOR CORBO
Correspondent
C.I.S.A. Import Export C/O Larson and Taylor
9 E. 41st St.
New York,  NY  10017
Correspondent Contact VICTOR CORBO
Regulation Number884.4530
Classification Product Code
HIB  
Date Received02/11/1988
Decision Date 12/20/1988
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
-
-