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 Forceps, Surgical, Gynecological
510(k) Number K944055
Device Name FORCEPS, SURGICAL GYNECOLOGICAL
Applicant
OWENS PRECISION SYSTEMS, INC.
7815 SOUTH 6TH ST.
OAK CREEK,  WI  53154
Applicant Contact LANIS P PFOLSGROF
Correspondent
OWENS PRECISION SYSTEMS, INC.
7815 SOUTH 6TH ST.
OAK CREEK,  WI  53154
Correspondent Contact LANIS P PFOLSGROF
Regulation Number884.4530
Classification Product Code
HCZ  
Date Received08/19/1994
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-