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 Drape, Surgical, Antimicrobial
510(k) Number K941802
Device Name OR TOWEL
Applicant
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Applicant Contact CHRISTINE SHEN
Correspondent
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Correspondent Contact CHRISTINE SHEN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/12/1994
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-