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 Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K931356
Device Name SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR
Applicant
Sorenson Laboratories, Inc.
2495 S. W. Temple
Salt Lake City,  UT  84115
Applicant Contact LINDA RITTENHOUSE
Correspondent
Sorenson Laboratories, Inc.
2495 S. W. Temple
Salt Lake City,  UT  84115
Correspondent Contact LINDA RITTENHOUSE
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received03/17/1993
Decision Date 09/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-