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, cryophthalmic
510(k) Number K801418
Device Name KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
Applicant
KEELER OPTICAL PRODUCTS LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KEELER OPTICAL PRODUCTS LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4170
Classification Product Code
HPS  
Date Received06/17/1980
Decision Date 07/21/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-