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 holder, needle, gastroenterologic
510(k) Number K930330
Device Name ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
Applicant
HOLMED CORP.
40 NORFOLK AVE.
SOUTH EASTON,  MA  02375
Applicant Contact RUSSELL P HOLMES
Correspondent
HOLMED CORP.
40 NORFOLK AVE.
SOUTH EASTON,  MA  02375
Correspondent Contact RUSSELL P HOLMES
Regulation Number876.4730
Classification Product Code
FHQ  
Date Received01/22/1993
Decision Date 06/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-