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, Phacofragmentation
510(k) Number K972253
Device Name P3 UNIVERSAL PHACO HANDPIECE
Applicant
Odyssey Technologies, Inc.
9327 Blackley St.
Temple City,  CA  91780
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
Odyssey Technologies, Inc.
9327 Blackley St.
Temple City,  CA  91780
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/16/1997
Decision Date 07/29/1997
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
-
-