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 Trephine, Manual, Ophthalmic
510(k) Number K860648
Device Name BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
Applicant
Precision Instruments, Inc.
6437 Carriage Hill Dr.
Grand Blanc,  MI  48439
Applicant Contact MILFORD BARRON
Correspondent
Precision Instruments, Inc.
6437 Carriage Hill Dr.
Grand Blanc,  MI  48439
Correspondent Contact MILFORD BARRON
Regulation Number886.4350
Classification Product Code
HRH  
Date Received02/20/1986
Decision Date 03/25/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-