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 Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K890463
Device Name ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
Applicant
Critical Specialties, Inc.
325 Westtown Rd.
West Chester,  PA  19382
Applicant Contact ARTHUR K FERRELL
Correspondent
Critical Specialties, Inc.
325 Westtown Rd.
West Chester,  PA  19382
Correspondent Contact ARTHUR K FERRELL
Regulation Number884.1550
Classification Product Code
HIO  
Date Received01/30/1989
Decision Date 04/07/1989
Decision Substantially Equivalent - With Drug (SESD)
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
-
-