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 Light, Surgical, Fiberoptic
510(k) Number K912252
Device Name INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
Applicant
Fiberoptic Medical Products, Inc.
4000 Bell Atlantic Tower
1717 Arch St.
Philadelphia,  PA  19103
Applicant Contact JOHN B REISS
Correspondent
Fiberoptic Medical Products, Inc.
4000 Bell Atlantic Tower
1717 Arch St.
Philadelphia,  PA  19103
Correspondent Contact JOHN B REISS
Regulation Number878.4580
Classification Product Code
FST  
Date Received05/21/1991
Decision Date 06/27/1991
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
-
-