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 Scale, Patient
510(k) Number K853475
Device Name GRAM-MA NEONATAL SC
Applicant
Kentec Medical, Inc.
17871 Fitch
Irvine,  CA  92614
Applicant Contact STEVE BECSI
Correspondent
Kentec Medical, Inc.
17871 Fitch
Irvine,  CA  92614
Correspondent Contact STEVE BECSI
Regulation Number880.2720
Classification Product Code
FRW  
Date Received08/20/1985
Decision Date 09/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-