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 catheter, ventricular, general & plastic surgery
510(k) Number K832416
Device Name AXIOM HYDROMER WOUND DRAINS
Applicant
AXIOM MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AXIOM MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBS  
Date Received07/21/1983
Decision Date 10/31/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-