• 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 Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K905206
Device Name INCARE PINSITE DRESSING
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Applicant Contact SHARON A LEAF
Correspondent
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Correspondent Contact SHARON A LEAF
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received11/20/1990
Decision Date 04/12/1991
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
-
-