• 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 kit, surgical instrument, disposable
510(k) Number K910816
Device Name IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
Applicant
INSIGHT INTERNATIONAL, INC.
500 PROSPECT ST.
PAWTUCKET,  RI  02860
Applicant Contact PHILLIP F JANES
Correspondent
INSIGHT INTERNATIONAL, INC.
500 PROSPECT ST.
PAWTUCKET,  RI  02860
Correspondent Contact PHILLIP F JANES
Regulation Number878.4800
Classification Product Code
KDD  
Date Received02/26/1991
Decision Date 04/17/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-