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 Laparoscope, General & Plastic Surgery
510(k) Number K950753
Device Name CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO
Applicant
STEPHEN CHAKOFF, INC.
15405 SOUTHWEST 72 CT.
MIAMI,  FL  33157
Applicant Contact FRANK GOLDFRAB
Correspondent
STEPHEN CHAKOFF, INC.
15405 SOUTHWEST 72 CT.
MIAMI,  FL  33157
Correspondent Contact FRANK GOLDFRAB
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/17/1995
Decision Date 05/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-