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 Tray, Surgical
510(k) Number K883098
Device Name SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
Applicant
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact MCCRACKEN
Correspondent
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact MCCRACKEN
Regulation Number878.4800
Classification Product Code
LRP  
Date Received07/22/1988
Decision Date 08/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-