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 products, contact lens care, rigid gas permeable
510(k) Number K974466
Device Name BOSTON ADVANCE CLEANER
Applicant
POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER,  NY  14692
Applicant Contact DOGULAS J FORTUNATO
Correspondent
POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER,  NY  14692
Correspondent Contact DOGULAS J FORTUNATO
Regulation Number886.5918
Classification Product Code
MRC  
Date Received11/26/1997
Decision Date 02/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-