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 Gown, Surgical
510(k) Number K210688
Device Name AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
Applicant
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Kimberly Lewis
Correspondent
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Correspondent Contact Kimberly Lewis
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/08/2021
Decision Date 07/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-