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 Tenaculum, Uterine
510(k) Number K891033
Device Name ATRAUMATIC TENACULA
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Applicant Contact ANNA STRAIGHT
Correspondent
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Correspondent Contact ANNA STRAIGHT
Regulation Number884.4530
Classification Product Code
HDC  
Date Received02/28/1989
Decision Date 03/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-