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 unit, cryosurgical, accessories
510(k) Number K193619
Device Name Cry-Ac®, Cry-Ac-3®, Cry-Baby
Applicant
Brymill Cryogenic Systems
105 Windermere Avenue, Suite 2B
Ellington,  CT  06029
Applicant Contact Paul Sideleau
Correspondent
G&L Scientific Inc.
25 Independence Blvd., Suite 404
Warren,  NJ  07059
Correspondent Contact Roshana Ahmed
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/26/2019
Decision Date 03/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-