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 Sponge, Ophthalmic
510(k) Number K972633
Device Name ULTRACELL SUCTION SPONGE
Applicant
Ultracell Medical Technologies, Inc.
183 Providence,
New London Tnpk
North Stonington,  CT  06359
Applicant Contact GEORGE P KORTEWEG
Correspondent
Ultracell Medical Technologies, Inc.
183 Providence,
New London Tnpk
North Stonington,  CT  06359
Correspondent Contact GEORGE P KORTEWEG
Regulation Number886.4790
Classification Product Code
HOZ  
Subsequent Product Code
HBA  
Date Received07/14/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-