• 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 Illuminator, Fiberoptic, Surgical Field
510(k) Number K883201
Device Name VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
Applicant
Vital Metrics, Inc.
11339 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact JEFFREY CASTLEBERRY
Correspondent
Vital Metrics, Inc.
11339 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact JEFFREY CASTLEBERRY
Regulation Number878.4580
Classification Product Code
HBI  
Date Received07/28/1988
Decision Date 09/26/1988
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
-
-