• 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 K883099
Device Name SITE MACROBORE PHACO NEEDLE
Applicant
SITE MICROSURGICAL SYSTEMS, INC.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Applicant Contact JAMES K MCCRACKEN
Correspondent
SITE MICROSURGICAL SYSTEMS, INC.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Correspondent Contact JAMES K MCCRACKEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/22/1988
Decision Date 09/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-